Science.gov

Sample records for pharmaceutical approval update

  1. Pharmaceutical Approval Update.

    PubMed

    Choy, Mary

    2016-07-01

    Defibrotide sodium (Defitelio) for hepatic veno-occlusive disease; emtricitabine/tenofovir alafenamide (Descovy) for human immunodeficiency virus infection; and infliximabdyyb (Inflectra) for Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. PMID:27408516

  2. Pharmaceutical Approval Update.

    PubMed

    Kaufman, Michele B

    2016-08-01

    Venetoclax (Venclexta) for chronic lymphocytic leukemia; riboflavin 5'-phosphate solutions (Photrexa Viscous and Photrexa) for progressive keratoconus; and pimavanserin (Nuplazid) for Parkinson's disease psychosis. PMID:27504063

  3. Pharmaceutical approval update.

    PubMed

    Goldenberg, Marvin M

    2013-06-01

    Extended-release carbinoxamine maleate oral suspension (Karbinaler) for allergicrhinitis; brinzolamide 1.0%/brimonidine tartrate 0.2% ophthalmic suspension (simbrinza) for open-angle glaucoma and ocular hypertension; and cysteamine bitartrate (Procysbi) for nephropathic cystinosis. PMID:23946626

  4. Pharmaceutical Approval Update.

    PubMed

    Gohil, Kunj

    2015-09-01

    Sacubitril/valsartan (Entresto) for chronic heart failure; brexpiprazole (Rexulti) for major depressive disorder and schizophrenia; and lumacaftor/ivacaftor (Orkambi) for cystic fibrosis involving specific CFTR mutations. PMID:26417173

  5. Pharmaceutical Approval Update.

    PubMed

    Fellner, Chris

    2015-12-01

    Idarucizumab (Praxbind) to reverse the anticoagulant effects of dabigatran (Pradaxa); aripiprazole lauroxil (Aristada) for the treatment of schizophrenia; and insulin degludec injection (Tresiba) for diabetes. PMID:26681901

  6. Pharmaceutical Approval Update.

    PubMed

    Fellner, Chris

    2016-02-01

    Lesinurad (Zurampic) for gout-related hyperuricemia; selexipag (Uptravi) for pulmonary arterial hypertension; sugammadex (Bridion) to reverse neuromuscular blockade after surgery; and alectinib (Alecensa) for lung cancer. PMID:26908998

  7. Pharmaceutical approval update.

    PubMed

    Gohil, Kunj

    2015-02-01

    Blinatumomab (Blincyto) for acute lymphoblastic leukemia; human papillomavirus 9-valent vaccine, recombinant (Gardasil 9) for extended protection against cervical cancer; and hydrocodone bitartrate extended release (Hysingla ER) for 24-hour management of severe pain. PMID:25673958

  8. Pharmaceutical approval update.

    PubMed

    Goldenberg, Marvin M

    2013-09-01

    Afatinib (Gilotrif) for non-small-cell lung cancer; golimumab (Simponi Aria) for moderate-to-severe active rheumatoid arthritis; and levomilnacipran (Fetzima) extended release for major depressive disorder. PMID:24273397

  9. Pharmaceutical Approval Update.

    PubMed

    Fellner, Chris

    2016-01-01

    Elotuzumab (Empliciti) and ixazomib (Ninlaro) for some multiple myeloma patients; Fluad (influenza vaccine, adjuvanted) for immunization of persons 65 years of age and older; and osimertinib (Tagrisso) for certain non-small-cell lung cancers. PMID:26766887

  10. Pharmaceutical Approval Update.

    PubMed

    Choy, Mary

    2016-05-01

    Coagulation factor IX (recombinant), albumin fusion protein (Idelvion) for hemophilia B; captisol-enabled melphalan hydrochloride (Evomela) for multiple myeloma; and antihemophilic factor (recombinant) (Kovaltry) for hemophilia A. PMID:27162467

  11. Pharmaceutical Approval Update.

    PubMed

    Gohil, Kunj

    2015-10-01

    Alirocumab (Praluent) for high cholesterol; flibanserin (Addyi) for sexual desire disorder in women; daclatasvir (Daklinza) for chronic hepatitis C virus (HCV) genotype 3 infection; and ombitasvir/paritaprevir/ritonavir (Technivie) for genotype 4 HCV infection without cirrhosis. PMID:26535020

  12. An updated review of long-term outcomes from randomized controlled trials in approved pharmaceuticals for diabetic macular edema.

    PubMed

    Wang, Jia-Kang; Huang, Tzu-Lun; Su, Pei-Yuan; Chang, Pei-Yao

    2015-12-01

    Diabetic macular edema (DME) is a major sight-threatening cause in diabetic patients. We review the long-term outcome of four approved pharmacotherapy for treating DME, including intravitreal injections of corticosteroids (dexamethasone implants and fluocinolone acetonide inserts) and anti-vascular endothelial growth factor (VEGF) (ranibizumab and aflibercept). They all show superior ability to improve vision and reduce macular thickness, comparing with sham injections or macular focal/grid laser treatment. Anti-VEGF agents result in low incidence of severe ocular or systemic adverse effects, but glaucoma and cataract should be aware after intravitreal corticosteroids. Prompt treatment with these agents can lead to a better outcome PMID:27215008

  13. Drug updates and approvals: 2015 in review.

    PubMed

    Klibanov, Olga M; Phan, Diep; Ferguson, Kelli

    2015-12-12

    This article highlights important prescribing information for some drugs that received FDA approval within the past year. These include: atazanavir and cobicistat (Evotaz®), ceftazidime and avibactam (Avycaz®), edoxaban (Savaysa®), ivabradine (Corlanor®), liraglutide (rDNA origin) injection (Saxenda®), perindopril arginine and amlodipine besylate (Prestalia®), and secukinumab (Cosentyx®) subcutaneous injection. PMID:26545091

  14. 78 FR 32367 - Approval of Subzone Status; Teva Pharmaceuticals USA, Inc.; North Wales, Chalfont, Kutztown and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-30

    ... Federal Register inviting public comment (78 FR 17634-17635, 3-22-2013). The FTZ staff examiner reviewed... Foreign-Trade Zones Board Approval of Subzone Status; Teva Pharmaceuticals USA, Inc.; North Wales... of Teva Pharmaceuticals USA, Inc., in North Wales, Chalfont, Kutztown and Sellersville,...

  15. 75 FR 28814 - FHA Lender Approval, Annual Renewal, Periodic Updates and Required Reports From FHA Approved Lenders

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-24

    ... URBAN DEVELOPMENT FHA Lender Approval, Annual Renewal, Periodic Updates and Required Reports From FHA...) Annual renewal of each FHA lender's approval, (3) Updates to a FHA lender's approval and (4) Various... CONTACT: Leroy McKinney, Jr., Reports Management Officer, QDAM, Department of Housing and...

  16. Hepatitis treatment update: new approvals, not much news.

    PubMed

    Learned, J

    Thymosin-Alpha-1 (Zadaxin) is a synthetic hormone that has been studied as a treatment for HIV, hepatitis B, and hepatitis C. Recently approved in Mexico as a booster for the flu vaccine, it was also approved in nine other countries for flu, hepatitis B, and hepatitis C. The demand for Thymosin is great but it is difficult to procure. A partnership between Schering-Plough and SciClone Pharmaceuticals has renewed hope that the demand for Thymosin will be met. Schering-Plough is also marketing Rebetron, a packaged combination of Ribavirin capsules and injectable alpha-interferon (Intron-A), for the treatment of hepatitis C. Other hepatitis treatments are described, such as Epivir-HBV (3TC, Epivir) which was approved in December for the treatment of Hepatitis B. Epivir-HBV has shown promising results. PMID:11366197

  17. Recombinant pharmaceuticals from microbial cells: a 2015 update.

    PubMed

    Sanchez-Garcia, Laura; Martín, Lucas; Mangues, Ramon; Ferrer-Miralles, Neus; Vázquez, Esther; Villaverde, Antonio

    2016-01-01

    Diabetes, growth or clotting disorders are among the spectrum of human diseases related to protein absence or malfunction. Since these pathologies cannot be yet regularly treated by gene therapy, the administration of functional proteins produced ex vivo is required. As both protein extraction from natural producers and chemical synthesis undergo inherent constraints that limit regular large-scale production, recombinant DNA technologies have rapidly become a choice for therapeutic protein production. The spectrum of organisms exploited as recombinant cell factories has expanded from the early predominating Escherichia coli to alternative bacteria, yeasts, insect cells and especially mammalian cells, which benefit from metabolic and protein processing pathways similar to those in human cells. Up to date, around 650 protein drugs have been worldwide approved, among which about 400 are obtained by recombinant technologies. Other 1300 recombinant pharmaceuticals are under development, with a clear tendency towards engineered versions with improved performance and new functionalities regarding the conventional, plain protein species. This trend is exemplified by the examination of the contemporary protein-based drugs developed for cancer treatment. PMID:26861699

  18. Three Newly Approved Analgesics: An Update

    PubMed Central

    Saraghi, Mana; Hersh, Elliot V.

    2013-01-01

    Since 2008, three new analgesic entities, tapentadol immediate release (Nucynta) diclofenac potassium soft gelatin capsules (Zipsor), and bupivacaine liposome injectable suspension (EXPAREL) were granted US Food and Drug Administration (FDA) approval to treat acute pain. Tapentadol immediate-release is a both a mu-opioid agonist and a norepinephrine reuptake inhibitor, and is indicated for the treatment of moderate to severe pain. Diclofenac potassium soft gelatin capsules are a novel formulation of diclofenac potassium, which is a nonsteroidal anti-inflammatory drug (NSAID), and its putative mechanism of action is through inhibition of cyclooxygenase enzymes. This novel formulation of diclofenac allows for improved absorption at lower doses. Liposomal bupivacaine is a new formulation of bupivacaine intended for single-dose infiltration at the surgical site for postoperative analgesia. Bupivacaine is slowly released from this liposomal vehicle and can provide prolonged analgesia at the surgical site. By utilizing NSAIDs and local anesthetics to decrease the transmission of afferent pain signals, less opioid analgesics are needed to achieve analgesia. Since drug-related adverse events are frequently dose related, lower doses from different drug classes may be employed to reduce the incidence of adverse effects, while producing synergistic analgesia as part of a multimodal analgesic approach to acute pain. PMID:24423420

  19. 75 FR 340 - Approval for Expansion of Subzone 22F, Abbott Molecular, Inc. (Pharmaceutical and Molecular...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-05

    ...- 17-09); Whereas, notice inviting public comment has been given in the Federal Register (74 FR 8052... Foreign-Trade Zones Board Approval for Expansion of Subzone 22F, Abbott Molecular, Inc. (Pharmaceutical and Molecular Diagnostic Products), Chicago, IL, Area Pursuant to its authority under the...

  20. 78 FR 48373 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Update of the Motor...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-08

    ... consists of an update to the SIP-approved Motor Vehicle Emissions Budgets (MVEBs) for nitrogen oxides (NO X... revision updates the point source inventory for NO X and VOCs. In the Final Rules section of this...

  1. Chitosan: An Update on Potential Biomedical and Pharmaceutical Applications

    PubMed Central

    Cheung, Randy Chi Fai; Ng, Tzi Bun; Wong, Jack Ho; Chan, Wai Yee

    2015-01-01

    Chitosan is a natural polycationic linear polysaccharide derived from chitin. The low solubility of chitosan in neutral and alkaline solution limits its application. Nevertheless, chemical modification into composites or hydrogels brings to it new functional properties for different applications. Chitosans are recognized as versatile biomaterials because of their non-toxicity, low allergenicity, biocompatibility and biodegradability. This review presents the recent research, trends and prospects in chitosan. Some special pharmaceutical and biomedical applications are also highlighted. PMID:26287217

  2. Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999–2014

    PubMed Central

    Hatswell, Anthony J; Baio, Gianluca; Berlin, Jesse A; Irs, Alar; Freemantle, Nick

    2016-01-01

    Introduction The efficacy of pharmaceuticals is most often demonstrated by randomised controlled trials (RCTs); however, in some cases, regulatory applications lack RCT evidence. Objective To investigate the number and type of these approvals over the past 15 years by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Methods Drug approval data were downloaded from the EMA website and the ‘Drugs@FDA’ database for all decisions on pharmaceuticals published from 1 January 1999 to 8 May 2014. The details of eligible applications were extracted, including the therapeutic area, type of approval and review period. Results Over the period of the study, 76 unique indications were granted without RCT results (44 by the EMA and 60 by the FDA), demonstrating that a substantial number of treatments reach the market without undergoing an RCT. The majority was for haematological malignancies (34), with the next most common areas being oncology (15) and metabolic conditions (15). Of the applications made to both agencies with a comparable data package, the FDA granted more approvals (43/44 vs 35/44) and took less time to review products (8.7 vs 15.5 months). Products reached the market first in the USA in 30 of 34 cases (mean 13.1 months) due to companies making FDA submission before EMA submissions and faster FDA review time. Discussion Despite the frequency with which approvals are granted without RCT results, there is no systematic monitoring of such treatments to confirm their effectiveness or consistency regarding when this form of evidence is appropriate. We recommend a more open debate on the role of marketing authorisations granted without RCT results, and the development of guidelines on what constitutes an acceptable data package for regulators. PMID:27363818

  3. Physicians and the pharmaceutical industry (update 1994). Canadian Medical Association.

    PubMed Central

    1994-01-01

    The history of health care delivery in Canada has been marked by close collaboration between physicians and the pharmaceutical and health supply industries, this collaboration extending to research as well as to education. Since medicine is a self-governing profession physicians have a responsibility to ensure that their participation in such collaborative efforts is in keeping with their duties toward their patients and society. The following guidelines have been developed by the CMA to assist physicians in determining when a relationship with industry is appropriate. Although directed primarily to individual physicians, including residents and interns as well as medical students, the guidelines also govern the relationships between industry and medical associations. These guidelines focus on the pharmaceutical companies; however, the CMA considers that the same principles apply to the relationship between its members and manufacturers of medical devices, infant formulas and similar products, and health care products and service suppliers in general. These guidelines reflect a national consensus and are meant to serve as an educational resource for physicians throughout Canada. PMID:8287348

  4. 78 FR 54200 - Approval and Promulgation of Air Quality Implementation Plans; Indiana; Maintenance Plan Update...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-03

    ... Plan Update for Lake County, Indiana for Sulfur Dioxide AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: EPA is proposing to approve a maintenance plan update for the Lake County, Indiana sulfur dioxide (SO 2 ) maintenance area. This plan update demonstrates that Lake County...

  5. 76 FR 22817 - Approval and Promulgation of Air Quality Implementation Plans; South Carolina; Update to...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-25

    ...EPA is publishing this action to provide the public with notice of the update to the South Carolina State Implementation Plan (SIP) compilation. In particular, materials submitted by South Carolina that are incorporated by reference (IBR) into the South Carolina SIP are being updated to reflect EPA-approved revisions to South Carolina's SIP that have occurred since the last update. In this......

  6. 77 FR 24723 - AstraZeneca Pharmaceuticals LP; Withdrawal of Approval of a New Drug Application for IRESSA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-25

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration AstraZeneca Pharmaceuticals LP; Withdrawal of Approval of a... IRESSA (gefitinib) Tablets held by AstraZeneca Pharmaceuticals LP (AstraZeneca), 1800 Concord Pike,...

  7. Fixed-Dose Combination Drug Approvals, Patents and Market Exclusivities Compared to Single Active Ingredient Pharmaceuticals

    PubMed Central

    Hao, Jing; Rodriguez-Monguio, Rosa; Seoane-Vazquez, Enrique

    2015-01-01

    Introduction Fixed-dose combinations (FDC) contain two or more active ingredients. The effective patent and exclusivity life of FDC compared to single active ingredient has not been assessed. Objectives Trends in FDA approved FDC in the period 1980–2012 and time lag between approval of FDC and single active ingredients in the combination were assessed, and the effective patent and exclusivity life of FDC was compared with their single active ingredients. Materials and Methods New molecular entities (NMEs), new therapeutic biologics license applications (BLAs) and FDC data were collected from the FDA Orange Book and Drugs@FDA. Analysis included FDC containing one or more NMEs or BLAs at first FDA approval (NMEs-FDC) and only already marketed drugs (Non-NMEs-FDC). Descriptive, Kruskal-Wallis and Wilcoxon Rank Sum analyses were performed. Results During the study period, the FDA approved 28 NMEs-FDC (3.5% of NMEs) and 117 non-NMEs-FDC. FDC approvals increased from 12 in the 1980s to 59 in the 2000s. Non-NMEs-FDC entered the market at a median of 5.43 years (interquartile range 1.74, 10.31) after first FDA approval of single active ingredients in the combination. The Non-NMEs-FDC entered the market at a median of 2.33 years (-7.55, 2.39) before approval of generic single active ingredient. Non-NME-FDC added a median of 9.70 (2.75, 16.24) years to the patent and exclusivity life of the single active ingredients in the combination. Conclusion FDC approvals significantly increased over the last twenty years. Pharmaceutical companies market FDC drugs shortly before the generic versions of the single ingredients enter the market extending the patent and exclusivity life of drugs included in the combination. PMID:26469277

  8. 78 FR 54173 - Approval and Promulgation of Air Quality Implementation Plans; Indiana; Maintenance Plan Update...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-03

    ...? On March 3, 1978 (43 FR 8962), EPA designated a portion of Lake County, Indiana as a primary... Plan Update for Lake County, Indiana for Sulfur Dioxide AGENCY: Environmental Protection Agency (EPA). ACTION: Direct final rule. SUMMARY: EPA is approving a maintenance plan update for the Lake...

  9. Savannah River Site Approved Site Treatment Plan, 1998 Annual Update

    SciTech Connect

    Lawrence, B.; Berry, M.

    1998-03-01

    The U.S. Department of Energy, Savannah River Operations Office (DOE- SR),has prepared the Site Treatment Plan (STP) for Savannah River Site (SRS) mixed wastes in accordance with RCRA Section 3021(b), and SCDHEC has approved the STP (except for certain offsite wastes) and issued an order enforcing the STP commitments in Volume I. DOE-SR and SCDHEC agree that this STP fulfills the requirements contained in the FFCAct, RCRA Section 3021, and therefore,pursuant to Section 105(a) of the FFCAct (RCRA Section 3021(b)(5)), DOE`s requirements are to implement the plan for the development of treatment capacities and technologies pursuant to RCRA Section 3021.Emerging and new technologies not yet considered may be identified to manage waste more safely, effectively, and at lower cost than technologies currently identified in the plan. DOE will continue to evaluate and develop technologies that offer potential advantages in public acceptance, privatization, consolidation, risk abatement, performance, and life-cycle cost. Should technologies that offer such advantages be identified, DOE may request a revision/modification of the STP in accordance with the provisions of Consent Order 95-22-HW.The Compliance Plan Volume (Volume I) identifies project activity schedule milestones for achieving compliance with Land Disposal Restrictions (LDR). Information regarding the technical evaluation of treatment options for SRS mixed wastes is contained in the Background Volume (Volume II) and is provided for information.

  10. 75 FR 75169 - Notice of Request for Extension of Approval of an Information Collection; Update of Nursery Stock...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-02

    ...; ] DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service Notice of Request for Extension of Approval of an Information Collection; Update of Nursery Stock Regulations AGENCY: Animal and Plant Health... Plant Health Inspection Service's intention to request extension of approval of an...

  11. Currently approved and emerging oral therapies in multiple sclerosis: An update for the ophthalmologist.

    PubMed

    Eckstein, Christopher; Bhatti, M Tariq

    2016-01-01

    Although our understanding of multiple sclerosis (MS) has grown substantially, its cause remains unknown. Nonetheless, in the past 3 decades, there have been tremendous advancements in the development of disease-modifying drugs (DMDs). In July 1993, the United States Food and Drug Administration approved the first disease-modifying drug-interferon β- and there are currently 13 medications approved for use in relapsing MS. All the early medications are administered either as a subcutaneous or intramuscular injection, and despite the clinical efficacy and safety of these medications, many patients were hampered by the inconvenience of injections and injection-related side effects. In September 2010, the first oral DMD-fingolimod-was approved. Since then, 2 additional oral DMDs (teriflunomide and dimethyl fumarate) have been approved, and several other oral medications are being evaluated in extensive MS development programs. Because of frequent ocular involvement, ophthalmologists are often involved in the care of MS patients and therefore need to be aware of the current treatment regimens prescribed by neurologists, some of which can have significant ophthalmic adverse events. We update the current advancements in the treatment of MS and discuss the published clinical data on the efficacy and safety of the currently approved and emerging oral therapies in MS. PMID:26703886

  12. How do patent rights affect regulatory approvals and data exclusivity rights for pharmaceuticals in the EU?

    PubMed

    Bogaert, Peter; Van Keymeulen, Eveline

    2012-09-01

    This article sheds light on the relationship, or rather, absence of a relationship, between patent rights and regulatory approval procedures in the EU. The principle of 'patent linkage' has long been recognized and applied by regulatory authorities in the USA. The European Commission, however, opposes the idea of linking patent rights to marketing authorizations and pricing and reimbursement decisions. This position is grounded in Article 126 of Directive 2001/83 and is expected not to change anytime soon, given the clear reaffirmation thereof in the recent Sector Inquiry Report and Transparency Directive Proposal. Therefore, the European Medicines Agency or national authorities are not permitted to refuse approval and, likely, pricing and reimbursement of a generic when the innovative reference product is still protected by a patent. The authors, however, advocate that there are strong legal arguments for patent holders to challenge regulatory decisions that did not respect their patent rights before the competent national courts. PMID:24236878

  13. WEBPAGE ON ENDOCRINE DISRUPTOR CHEMICALS, PHARMACEUTICALS, AND PERSONAL CARE PRODUCTS - UPDATE 6/28/02

    EPA Science Inventory

    The presence of endocrine disruptors, pharmaceuticals, and personal care products in the environment and in drinking waters is a growing concern in the US. The definition of endocrine disruptors is a matter of debate, however, a simple definition is that endocrine disruptors are ...

  14. The Effects of Pharmaceutical Excipients on Gastrointestinal Tract Metabolic Enzymes and Transporters-an Update.

    PubMed

    Zhang, Wenpeng; Li, Yanyan; Zou, Peng; Wu, Man; Zhang, Zhenqing; Zhang, Tao

    2016-07-01

    Accumulating evidence from the last decade has shown that many pharmaceutical excipients are not pharmacologically inert but instead have effects on metabolic enzymes and/or drug transporters. Hence, the absorption, distribution, metabolism, and elimination (ADME) of active pharmaceutical ingredients (APIs) may be altered due to the modulation of their metabolism and transport by excipients. The impact of excipients is a potential concern for Biopharmaceutics Classification System (BCS)-based biowaivers, particularly as the BCS-based biowaivers have been extended to class 3 drugs in certain dosage forms. The presence of different excipients or varying amounts of excipients between formulations may result in bio-inequivalence. The excipient impact may lead to significant variations in clinical outcomes as well. The aim of this paper is to review the recent findings of excipient effects on gastrointestinal (GI) absorption, focusing on their interactions with the metabolic enzymes and transporters in the GI tract. A wide range of commonly used excipients such as binders, diluents, fillers, solvents, and surfactants are discussed here. We summarized the reported effects of those excipients on GI tract phase I and phase II enzymes, uptake and efflux transporters, and relevant clinical significance. This information can enhance our understanding of excipient influence on drug absorption and is useful in designing pharmacokinetic studies and evaluating the resultant data. PMID:27184579

  15. A Comprehensive Updated Review of Pharmaceutical and Nonpharmaceutical Treatment for NAFLD

    PubMed Central

    Hossain, Newaz; Kanwar, Pushpjeet; Mohanty, Smruti R.

    2016-01-01

    Nonalcoholic fatty liver disease (NAFLD) is the most common liver disease in the western world with prevalence of 20–33%. NAFLD comprises a pathological spectrum. Nonalcoholic fatty liver (NAFL) is at one end and consists of simple hepatic steatosis. On the contrary, nonalcoholic steatohepatitis (NASH) consists of steatosis, inflammation, and ballooning degeneration and can progress to cirrhosis. Despite the rising incidence, definitive treatment for NAFLD, specifically NASH, has not yet been established. Lifestyle modification with dietary changes combined with regular aerobic exercise, along with multidisciplinary approach including cognitive behavior therapy, has been shown to be an effective therapeutic option, even without a significant weight loss. Pioglitazone and vitamin E have shown to be most effective in NASH patients. Surgery and weight loss medication are effective means of weight loss but can potentially worsen NASH related fibrosis. Other agents such as n-3 polyunsaturated fatty acids, probiotics, and pentoxifylline along with herbal agent such as milk thistle as well as daily intake of coffee have shown potential benefits, but further well organized studies are definitely warranted. This review focuses on the available evidence on pharmaceutical and nonpharmaceutical therapy in the treatment and the prevention of NAFLD, primarily NASH. PMID:27006654

  16. A Comprehensive Updated Review of Pharmaceutical and Nonpharmaceutical Treatment for NAFLD.

    PubMed

    Hossain, Newaz; Kanwar, Pushpjeet; Mohanty, Smruti R

    2016-01-01

    Nonalcoholic fatty liver disease (NAFLD) is the most common liver disease in the western world with prevalence of 20-33%. NAFLD comprises a pathological spectrum. Nonalcoholic fatty liver (NAFL) is at one end and consists of simple hepatic steatosis. On the contrary, nonalcoholic steatohepatitis (NASH) consists of steatosis, inflammation, and ballooning degeneration and can progress to cirrhosis. Despite the rising incidence, definitive treatment for NAFLD, specifically NASH, has not yet been established. Lifestyle modification with dietary changes combined with regular aerobic exercise, along with multidisciplinary approach including cognitive behavior therapy, has been shown to be an effective therapeutic option, even without a significant weight loss. Pioglitazone and vitamin E have shown to be most effective in NASH patients. Surgery and weight loss medication are effective means of weight loss but can potentially worsen NASH related fibrosis. Other agents such as n-3 polyunsaturated fatty acids, probiotics, and pentoxifylline along with herbal agent such as milk thistle as well as daily intake of coffee have shown potential benefits, but further well organized studies are definitely warranted. This review focuses on the available evidence on pharmaceutical and nonpharmaceutical therapy in the treatment and the prevention of NAFLD, primarily NASH. PMID:27006654

  17. Analysis of the landscape of biologically-derived pharmaceuticals in Europe: dominant production systems, molecule types on the rise and approval trends.

    PubMed

    Kyriakopoulos, Sarantos; Kontoravdi, Cleo

    2013-02-14

    A thorough sort of the human drugs approved by the European Medicines Agency (EMA) between its establishment in 1995 until June 2012 is presented herein with a focus on biologically-derived pharmaceuticals. Over 200 (33%) of the 640 approved therapeutic drugs are derived from natural sources, produced via recombinant DNA technology, or generated through virus propagation. A breakdown based on production method, type of molecule and therapeutic category is presented. Current EMA approvals demonstrate that mammalian cells are the only choice for glycoprotein drugs, with Chinese hamster ovary cells being the dominant hosts for their production. On the other hand, bacterial cells and specifically Escherichia coli are the dominant hosts for protein-based drugs, followed by the yeast Saccharomyces cerevisiae. The latter is the dominant host for recombinant vaccine production, although egg-based production is still the main platform of vaccine provision. Our findings suggest that the majority of biologically-derived drugs are prescribed for cancer and related conditions, as well as the treatment of diabetes. The approval rate for biologically-derived drugs shows a strong upward trend for monoclonal antibodies and fusion proteins since 2009, while hormones, antibodies and growth factors remain the most populous categories. Despite a clear pathway for the approval of biosimilars set by the EMA and their potential to drive sales growth, we have only found approved biosimilars for three molecules. In 2012 there appears to be a slow-down in approvals, which coincides with a reported decline in the growth rate of biologics sales. PMID:23262060

  18. 75 FR 42455 - Novartis Pharmaceuticals Corp. et al.; Withdrawal of Approval of 27 New Drug Applications and 58...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-21

    ...., Chadds Tablets Ford, PA 19317 ] NDA 16-023 Symmetrel (amantadine hydrochloride Do. (HCl) USP) Syrup NDA... (amantadine HCl USP) Syrup Endo Pharmaceuticals NDA 17-255 MPI DTPA Chelate multidose (kit for...

  19. 77 FR 40367 - Wyeth Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application for DURACT Capsules

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-09

    ... DURACT (bromfenac sodium) Capsules, held by Wyeth Pharmaceuticals, Inc. (Wyeth), P.O. Box 8299.... SUPPLEMENTARY INFORMATION: In June 1998, Wyeth voluntarily withdrew DURACT (bromfenac sodium) Capsules from the market. DURACT (bromfenac sodium) Capsules, a nonsteroidal anti-inflammatory drug indicated for the...

  20. 76 FR 64017 - Approval and Promulgation of Air Quality Implementation Plans; South Carolina; Update to...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-17

    ...On April 25, 2011, EPA published a final rule providing the public with notice of the update to the South Carolina State Implementation Plan (SIP) compilation. This action corrects typographical errors in the regulatory language in EPA's April 25, 2011, final...

  1. 77 FR 35279 - Approval and Promulgation of Implementation Plans; Arizona; Update to Stage II Gasoline Vapor...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-13

    ...Under the Clean Air Act, EPA is taking final action to approve certain revisions to the Arizona State Implementation Plan submitted by the Arizona Department of Environmental Quality. These revisions concern amendments to the statutory and regulatory provisions adopted by the State of Arizona to regulate volatile organic compound emissions from the transfer of gasoline from storage tanks to......

  2. 76 FR 61062 - Approval and Promulgation of Implementation Plans; Arizona; Update to Stage II Gasoline Vapor...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-03

    ... Refueling Vapor Recovery and Stage II Waiver,'' 76 FR 41731, at 41734 (July 15, 2011). \\2\\ By letter dated.... See 61 FR 3578 (February 1, 1996). MCAQDM's stage I vapor recovery program and related rule are not... provisions in the Arizona SIP? On November 1, 1994 (59 FR 54521), we approved Arizona's stage II...

  3. 78 FR 48323 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Update of the Motor...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-08

    ... the point source inventory for NO X and VOCs. On July 18, 1997 (62 FR 38856), EPA established the 1997 8-Hour Ozone NAAQS. On April 30, 2004 (69 FR 23857), Lancaster County was designated as... supplemented their September 20, 2006 submittal. On July 6, 2007 (72 FR 36889), EPA approved the SIP...

  4. 76 FR 49391 - Approval and Promulgation of Air Quality Implementation Plans; Minnesota; Rules Update

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-10

    ... disapprove the state's request to remove the Minneapolis/ St. Paul vehicle inspection and maintenance program... AGENCY 40 CFR Part 52 Approval and Promulgation of Air Quality Implementation Plans; Minnesota; Rules... Minnesota's rules in the SIP. The Minnesota Pollution Control Agency (MPCA) submitted the SIP revision...

  5. Fusion strategies for selecting multiple tuning parameters for multivariate calibration and other penalty based processes: A model updating application for pharmaceutical analysis.

    PubMed

    Tencate, Alister J; Kalivas, John H; White, Alexander J

    2016-05-19

    New multivariate calibration methods and other processes are being developed that require selection of multiple tuning parameter (penalty) values to form the final model. With one or more tuning parameters, using only one measure of model quality to select final tuning parameter values is not sufficient. Optimization of several model quality measures is challenging. Thus, three fusion ranking methods are investigated for simultaneous assessment of multiple measures of model quality for selecting tuning parameter values. One is a supervised learning fusion rule named sum of ranking differences (SRD). The other two are non-supervised learning processes based on the sum and median operations. The effect of the number of models evaluated on the three fusion rules are also evaluated using three procedures. One procedure uses all models from all possible combinations of the tuning parameters. To reduce the number of models evaluated, an iterative process (only applicable to SRD) is applied and thresholding a model quality measure before applying the fusion rules is also used. A near infrared pharmaceutical data set requiring model updating is used to evaluate the three fusion rules. In this case, calibration of the primary conditions is for the active pharmaceutical ingredient (API) of tablets produced in a laboratory. The secondary conditions for calibration updating is for tablets produced in the full batch setting. Two model updating processes requiring selection of two unique tuning parameter values are studied. One is based on Tikhonov regularization (TR) and the other is a variation of partial least squares (PLS). The three fusion methods are shown to provide equivalent and acceptable results allowing automatic selection of the tuning parameter values. Best tuning parameter values are selected when model quality measures used with the fusion rules are for the small secondary sample set used to form the updated models. In this model updating situation, evaluation of

  6. Development and validation of simple spectrophotometric and chemometric methods for simultaneous determination of empagliflozin and metformin: Applied to recently approved pharmaceutical formulation.

    PubMed

    Ayoub, Bassam M

    2016-11-01

    New univariate spectrophotometric method and multivariate chemometric approach were developed and compared for simultaneous determination of empagliflozin and metformin manipulating their zero order absorption spectra with application on their pharmaceutical preparation. Sample enrichment technique was used to increase concentration of empagliflozin after extraction from tablets to allow its simultaneous determination with metformin without prior separation. Validation parameters according to ICH guidelines were satisfactory over the concentration range of 2-12μgmL(-1) for both drugs using simultaneous equation with LOD values equal to 0.20μgmL(-1) and 0.19μgmL(-1), LOQ values equal to 0.59μgmL(-1) and 0.58μgmL(-1) for empagliflozin and metformin, respectively. While the optimum results for the chemometric approach using partial least squares method (PLS-2) were obtained using concentration range of 2-10μgmL(-1). The optimized validated methods are suitable for quality control laboratories enable fast and economic determination of the recently approved pharmaceutical combination Synjardy® tablets. PMID:27288963

  7. An Update of the Brazilian Regulatory Bioequivalence Recommendations for Approval of Generic Topical Dermatological Drug Products.

    PubMed

    Soares, Kelen Carine Costa; Santos, Gustavo Mendes Lima; Gelfuso, Guilherme M; Gratieri, Tais

    2015-11-01

    This note aims to clarify the Brazilian regulatory bioequivalence recommendations for approval of generic topical dermatological drug products, since the legal framework of the "Brazilian Health Surveillance Agency" (ANVISA) is only available in Portuguese. According to Resolutions RE n. 1170 (December 19th 2006) and RDC n. 37 (August 3rd 2011) in Brazil, only in vitro studies are required for registration of generic topical dermatological drug products. Current Regulatory Agenda of ANVISA, which contains possible future resolutions to be revised over 2015-2016, includes a discussion on biowaiver requirements and on possible in vitro and in vivo comparability tests for these products. PMID:26122498

  8. WHO Expert Committee on Specifications for Pharmaceutical Preparations.

    PubMed

    2014-01-01

    The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use, in addition to 20 monographs and general texts for inclusion in The International Pharmacopoeia and 11 new International Chemical Reference Substances. The International Pharmacopoeia--updating mechanism for the section on radiopharmaceuticals; WHO good manufacturing practices for pharmaceutical products: main principles; Model quality assurance system for procurement agencies; Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection; Guidelines on submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities; and Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product: quality part. PMID:24964711

  9. 42 CFR 495.344 - Approval of the State Medicaid HIT plan, the HIT PAPD and update, the HIT IAPD and update, and...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...) STANDARDS AND CERTIFICATION STANDARDS FOR THE ELECTRONIC HEALTH RECORD TECHNOLOGY INCENTIVE PROGRAM... include all of the information required under this subpart. ... 42 Public Health 5 2010-10-01 2010-10-01 false Approval of the State Medicaid HIT plan, the...

  10. GW-1000. GW Pharmaceuticals.

    PubMed

    Smith, Paul F

    2004-07-01

    GW Pharmaceuticals is developing GW-1000 (Sativex), a narrow ratio delta9-tetrahydrocannabinol:cannabidiol product for the potential treatment of multiple sclerosis, spinal cord injury, neurogenic pain and peripheral neuropathy. In March 2003, the company filed for approval for the treatment of MS with the UK Medicines Control Agency, and in May 2004, filed for new drug submission with Health Canada. PMID:15298072

  11. Pharmacovigilance during the pre-approval phases: an evolving pharmaceutical industry model in response to ICH E2E, CIOMS VI, FDA and EMEA/CHMP risk-management guidelines.

    PubMed

    Hartford, Craig G; Petchel, Kasia S; Mickail, Hani; Perez-Gutthann, Susana; McHale, Mary; Grana, John M; Marquez, Paula

    2006-01-01

    Pharmacovigilance science has traditionally been a discipline focussed on the postmarketing or post-authorisation period, with due attention directed towards pre-clinical safety data, clinical trials and adverse events. As the biological sciences have evolved, pharmacovigilance has slowly shifted toward earlier, proactive consideration of risks and potential benefits of drugs in the pre- and peri-approval stages of drug development, leading to a maturing of drug safety risk management. Further advances in biology, pharmacology and improvements in computational applications to medicine have led to the development of more complex medicines previously unobtainable and have also permitted a more thorough assessment of risks and potential benefits even earlier in the development process. Elevated public concern with the safety of more sophisticated medicines, combined with new science, have led pharmaceutical innovators, regulators and healthcare professionals to collaborate to develop guidelines, which drive enhanced pharmacovigilance and safety risk management earlier in drug development. In this paper, we review international guidelines on pharmacovigilance planning applicable to the pre-approval phases of medicines development and provide author opinion on these guidelines' potential drug safety implications. We discuss the possible evolution of a pharmaceutical industry model to respond to these guidelines; a view on multidisciplinary safety management teams is provided to encourage refinement of safety-signal identification and risk assessment early in drug development and to communicate important safety concerns to internal research efforts, patients, investigators and regulators. We further describe these functions in the context of the complexities of vulnerable populations, including the example of medicines research for paediatric populations. We also discuss the special role of epidemiology in pre-approval drug development and the impact on epidemiological

  12. Simultaneous spectrophotometric determination of indacaterol and glycopyrronium in a newly approved pharmaceutical formulation using different signal processing techniques of ratio spectra

    NASA Astrophysics Data System (ADS)

    Abdel Ghany, Maha F.; Hussein, Lobna A.; Magdy, Nancy; Yamani, Hend Z.

    2016-03-01

    Three spectrophotometric methods have been developed and validated for determination of indacaterol (IND) and glycopyrronium (GLY) in their binary mixtures and novel pharmaceutical dosage form. The proposed methods are considered to be the first methods to determine the investigated drugs simultaneously. The developed methods are based on different signal processing techniques of ratio spectra namely; Numerical Differentiation (ND), Savitsky-Golay (SG) and Fourier Transform (FT). The developed methods showed linearity over concentration range 1-30 and 10-35 (μg/mL) for IND and GLY, respectively. The accuracy calculated as percentage recoveries were in the range of 99.00%-100.49% with low value of RSD% (< 1.5%) demonstrating an excellent accuracy of the proposed methods. The developed methods were proved to be specific, sensitive and precise for quality control of the investigated drugs in their pharmaceutical dosage form without the need for any separation process.

  13. Simultaneous spectrophotometric determination of indacaterol and glycopyrronium in a newly approved pharmaceutical formulation using different signal processing techniques of ratio spectra.

    PubMed

    Abdel Ghany, Maha F; Hussein, Lobna A; Magdy, Nancy; Yamani, Hend Z

    2016-03-15

    Three spectrophotometric methods have been developed and validated for determination of indacaterol (IND) and glycopyrronium (GLY) in their binary mixtures and novel pharmaceutical dosage form. The proposed methods are considered to be the first methods to determine the investigated drugs simultaneously. The developed methods are based on different signal processing techniques of ratio spectra namely; Numerical Differentiation (ND), Savitsky-Golay (SG) and Fourier Transform (FT). The developed methods showed linearity over concentration range 1-30 and 10-35 (μg/mL) for IND and GLY, respectively. The accuracy calculated as percentage recoveries were in the range of 99.00%-100.49% with low value of RSD% (<1.5%) demonstrating an excellent accuracy of the proposed methods. The developed methods were proved to be specific, sensitive and precise for quality control of the investigated drugs in their pharmaceutical dosage form without the need for any separation process. PMID:26779820

  14. Update on medical and regulatory issues pertaining to compounded and FDA-approved drugs, including hormone therapy

    PubMed Central

    Pinkerton, JoAnn V.; Pickar, James H.

    2016-01-01

    Abstract Objective: We review the historical regulation of drug compounding, concerns about widespread use of non-Food and Drug Admiistration (FDA)-approved compounded bioidentical hormone therapies (CBHTs), which do not have proper labeling and warnings, and anticipated impact of the 2013 Drug Quality and Security Act (DQSA) on compounding. Methods: US government websites were searched for documents concerning drug compounding regulation and oversight from 1938 (passage of Federal Food, Drug, and Cosmetic Act [FDCA]) through 2014, including chronologies, Congressional testimony, FDA guidelines and enforcements, and reports. The FDCA and DQSA were reviewed. PubMed and Google were searched for articles on compounded drugs, including CBHT. Results: Congress explicitly granted the FDA limited oversight of compounded drugs in a 1997 amendment to the FDCA, but the FDA has encountered obstacles in exercising that authority. After 64 patient deaths and 750 adversely affected patients from the 2012 meningitis outbreak due to contaminated compounded steroid injections, Congress passed the DQSA, authorizing the FDA to create a voluntary registration for facilities that manufacture and distribute sterile compounded drugs in bulk and reinforcing FDCA regulations for traditional compounding. Given history and current environment, concerns remain about CBHT product regulation and their lack of safety and efficacy data. Conclusions: The DQSA and its reinforcement of §503A of the FDCA solidifies FDA authority to enforce FDCA provisions against compounders of CBHT. The new law may improve compliance and accreditation by the compounding industry; support state and FDA oversight; and prevent the distribution of misbranded, adulterated, or inconsistently compounded medications, and false and misleading claims, thus reducing public health risk. PMID:26418479

  15. Lessons from 60 years of pharmaceutical innovation.

    PubMed

    Munos, Bernard

    2009-12-01

    Despite unprecedented investment in pharmaceutical research and development (R&D), the number of new drugs approved by the US Food and Drug Administration (FDA) remains low. To help understand this conundrum, this article investigates the record of pharmaceutical innovation by analysing data on the companies that introduced the approximately 1,200 new drugs that have been approved by the FDA since 1950. This analysis shows that the new-drug output from pharmaceutical companies in this period has essentially been constant, and remains so despite the attempts to increase it. This suggests that, contrary to common perception, the new-drug output is not depressed, but may simply reflect the limitations of the current R&D model. The implications of these findings and options to achieve sustainability for the pharmaceutical industry are discussed. PMID:19949401

  16. Pimavanserin: First Global Approval.

    PubMed

    Markham, Anthony

    2016-07-01

    Pimavanserin (Nuplazid™) is a selective and potent serotonin 2A (5-HT2A) receptor inverse agonist and antagonist developed by ACADIA Pharmaceuticals that has been approved in the US as a treatment for patients with hallucinations and delusions associated with Parkinson's disease psychosis. Up to 60 % of patients with Parkinson's disease may develop Parkinson's disease psychosis, which is associated with increased morbidity and mortality and has few treatment options. This article summarizes the milestones in the development of pimavanserin leading to this first approval for the treatment of hallucinations and delusions in patients with Parkinson's disease psychosis. PMID:27262680

  17. Meeting the pharmaceutical needs of a developing country.

    PubMed

    Froese, E H

    1991-01-01

    Zimbabwe is making advances in the selection, procurement, distribution, storage, management and use of pharmaceutical products. The periodic updating of the country's essential drugs list is a vital part of this process. PMID:1859593

  18. Pharmaceutical Analysis as a Branch of Pharmaceutics

    ERIC Educational Resources Information Center

    Connors, Kenneth A.

    1977-01-01

    Pharmaceutical analysis is incorporated into the pharmaceutics component of the undergraduate curriculum at the University of Wisconsin. Many collaborative demonstrations, lectures, and laboratory experiments can illustrate the close relationship between analysis and modern pharmacy practice. (Author/LBH)

  19. Brexpiprazole: First Global Approval.

    PubMed

    Greig, Sarah L

    2015-09-01

    Brexpiprazole (Rexulti®) is an atypical antipsychotic that has been developed by Otsuka Pharmaceutical Co. Ltd and H. Lundbeck A/S as an oral treatment for several psychiatric disorders. Brexpiprazole is a novel serotonin-dopamine activity modulator that acts as a partial agonist of serotonin 1A (5-HT1A) and dopamine D2 receptors, as well as a potent antagonist of 5-HT2A receptors and noradrenergic α1B and α2C receptors. In July 2015, brexpiprazole received its first approval in the USA for use as an adjunctive treatment of major depressive disorder (MDD) and the treatment of schizophrenia. In several countries, brexpiprazole is in development for MDDs, schizophrenia, post-traumatic stress disorder and agitation in patients with dementia of the Alzheimer's type. This article summarizes the milestones in the development of brexpiprazole leading to its first global approval in MDD and schizophrenia. PMID:26310190

  20. Alirocumab: First Global Approval.

    PubMed

    Markham, Anthony

    2015-09-01

    Alirocumab (Praluent®) is a fully human monoclonal antibody developed by Regeneron Pharmaceuticals and Sanofi that has been approved in the US as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolaemia (HeFH) or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-C. It specifically binds proprotein convertase subtilisin/kexin type 9 (PCSK9)-a down regulator of liver low-density lipoprotein (LDL)-receptors-thereby increasing the ability of the liver to bind LDL-cholesterol (LDL-C) and reducing levels of LDL-C in blood. It has been shown to reduce LDL-C levels in patients with hypercholesterolaemia, including HeFH, both as monotherapy and in conjunction with statin therapy. This article summarizes the milestones in the development of alirocumab leading to this first approval. PMID:26370210

  1. Flibanserin: First Global Approval.

    PubMed

    Deeks, Emma D

    2015-10-01

    Flibanserin (Addyi™) is chemically described as a benzimidazole and is being developed by Sprout Pharmaceuticals for the treatment of hypoactive sexual desire disorder (HSDD). The drug has a high affinity for serotonin 5-HT1A and 5-HT2A receptors (5-HT1A agonist/5-HT2A antagonist) and is believed to treat HSDD by increasing levels of dopamine and noradrenaline and lowering levels of serotonin in the brain. Flibanserin has been approved in the USA for the treatment of premenopausal women with acquired, generalized HSDD. Earlier phase III development of the agent for HSDD in the EU and Canada had been discontinued by Boehringer Ingelheim, following regulatory feedback. Boehringer Ingelheim had also evaluated flibanserin for the treatment of depression but, due to displaying very mild antidepressant activity, its development in this indication was discontinued. This article summarizes the milestones in the development of flibanserin leading to its first approval for HSDD. PMID:26412054

  2. Pharmaceutical expenditure in Sweden.

    PubMed

    Henriksson, F; Hjortsberg, C; Rehnberg, C

    1999-05-01

    Recently, the responsibility for prescribed pharmaceuticals in Sweden was transferred from national level to the regional health authorities (county councils). The purpose was that a closer integration and balance between pharmaceuticals and other factors of production in health care should produce better opportunities for a cost-effective use of the total health care resources. The purpose of this paper is to present a deeper analysis of pharmaceuticals as a production factor in Sweden, mainly during the 1990s, and to discuss the future development and future policy decisions in Sweden. Pharmaceuticals have increased their share of total health care expenditure in Sweden, from about 9% in 1990 to about 14% in 1995. The Swedish pharmaceutical market can be divided into sub-markets, where the prescription sub-market accounts for the greater part of pharmaceutical expenditure. Further, a few disease categories account for a larger fraction of the cost of prescribed pharmaceuticals. The importance of pharmaceuticals as a production factor also differs between different age groups. Several factors are expected to contribute to a future increase in Swedish pharmaceutical expenditure, for instance an ageing population and the rapid introduction of expensive new pharmaceuticals. PMID:10538288

  3. Basic principles of pharmaceutical science in Ayurvĕda.

    PubMed

    Subhose, Varanasi; Srinivas, Pitta; Narayana, Ala

    2005-01-01

    Pharmaceutical is one of the allied branches of science, which is closely associated with Medical science. Today pharmaceutical chemistry and pharmacognosy are playing important role in treatment for a disease and its prevention. Herbal medicines are being used by about 80% of the world population mostly in the developing countries in the primary health care. There has been an upsurge in demand for the Phyto-pharmaceutical products of Ayurvĕda in western nations, because of the fact that the synthetic drugs are considered to be unsafe. Due to this many national and multinational pharmaceutical companies are now concentrating on manufacturing of Ayurvĕdic Phyto-pharmaceutical products. Ayurvĕda is the Indian traditional system of medicine, which also deals about pharmaceutical science. The Ayurvĕdic knowledge of the pharmaceutical science is scattered in Ayurvĕdic classical texts. Săranghadhara Samhita, which is written by Săranghadhara, explain systematically about the information of the Ayurvĕdic pharmaceutical science and also updated it. Industrialized manufacturing of Ayurvĕdic dosage forms has brought in new challenges like deviation from basic concepts of medicine preparation. Săranghadhara Samrhită the devout text on pharmaceutics in Ayurvĕda comes handy to solve such problems, as the methods described are very lucid and easy to follow. PMID:17333665

  4. Selected aspects of europeization of pharmaceutical law.

    PubMed

    Zimmermann, Agnieszka; Wengler, Lubomira; Pawłowski, Leszek

    2010-01-01

    As one of its aspects, the process of European integration has an influence on the legal orders of the Member States, which is often referred to in the literature as the europeization of law. Upon Poland's accession to the structures of the European Union, there have also been radical changes to the Polish legal system. According to the concept of the sources of law in the Polish Constitution and to the judicial decisions of the European Court of Justice, Community law now takes priority over national law, even over acts of parliament. Pharmaceutical law represents one of the areas where the harmonization process has been taking place. It shapes the principles and the manner according to which medicinal products are approved for marketing, the conditions of clinical trials, as well as the conditions of drug manufacture and advertisement. It also determines the rules of trading in medicinal products, the running of pharmaceutical wholesalers and pharmacies, as well as the duties and rights of the Pharmaceutical Inspectorate. This paper provides a summary of research on the impact of Community law on Polish pharmaceutical law, i.e. on the europeization process, and on the consequences of this process for the Polish pharmaceutical market and for research and development. PMID:20369799

  5. 'Linkage' pharmaceutical evergreening in Canada and Australia.

    PubMed

    Faunce, Thomas A; Lexchin, Joel

    2007-01-01

    'Evergreening' is not a formal concept of patent law. It is best understood as a social idea used to refer to the myriad ways in which pharmaceutical patent owners utilise the law and related regulatory processes to extend their high rent-earning intellectual monopoly privileges, particularly over highly profitable (either in total sales volume or price per unit) 'blockbuster' drugs. Thus, while the courts are an instrument frequently used by pharmaceutical brand name manufacturers to prolong their patent royalties, 'evergreening' is rarely mentioned explicitly by judges in patent protection cases. The term usually refers to threats made to competitors about a brand-name manufacturer's tactical use of pharmaceutical patents (including over uses, delivery systems and even packaging), not to extension of any particular patent over an active product ingredient. This article focuses in particular on the 'evergreening' potential of so-called 'linkage' provisions, imposed on the regulatory (safety, quality and efficacy) approval systems for generic pharmaceuticals of Canada and Australia, by specific articles in trade agreements with the US. These 'linkage' provisions have also recently appeared in the Korea-US Free Trade Agreement (KORUSFTA). They require such drug regulators to facilitate notification of, or even prevent, any potential patent infringement by a generic pharmaceutical manufacturer. This article explores the regulatory lessons to be learnt from Canada's and Australia's shared experience in terms of minimizing potential adverse impacts of such 'linkage evergreening' provisions on drug costs and thereby potentially on citizen's access to affordable, essential medicines. PMID:17543113

  6. Biological and Pharmaceutical Nanomaterials

    NASA Astrophysics Data System (ADS)

    Kumar, Challa S. S. R.

    2006-01-01

    This first comprehensive yet concise overview of all important classes of biological and pharmaceutical nanomaterials presents in one volume the different kinds of natural biological compounds that form nanomaterials or that may be used to purposefully create them. This unique single source of information brings together the many articles published in specialized journals, which often remain unseen by members of other, related disciplines. Covering pharmaceutical, nucleic acid, peptide and DNA-Chitosan nanoparticles, the book focuses on those innovative materials and technologies needed for the continued growth of medicine, healthcare, pharmaceuticals and human wellness. For chemists, biochemists, cell biologists, materials scientists, biologists, and those working in the pharmaceutical and chemical industries.

  7. The UK pharmaceutical market. An overview.

    PubMed

    Towse, A

    1996-01-01

    The National Health Service (NHS) accounts for more than 98% of the UK prescription medicines market, which is the sixth largest pharmaceutical market in the world. Most of this market is driven by the UK's approximately 35,000 general practitioners (GPs). It is an open market, with most leading foreign pharmaceutical companies having a strong presence. While the growth rate of this market has been decelerating, it remains one of the fastest growing components of NHS expenditure. The NHS does not operate any kind of national reimbursement list, but the UK government has adopted several means to keep medicines expenditure under control. These include cash incentives and constraints for GPs relating to expenditure on medicines, individual quarterly updates on GP prescribing, the publication of a list of medicines that cannot be prescribed by GPs, the switching of some prescription-only medicines to over-the-counter medicines, and a co-payment system. The main form of economic regulation in the UK, however, remains the Pharmaceutical Price Regulation Scheme (PPRS). This limits the rate-of-return on capital attributable to medicines sales to the NHS, with the intended rate-of-return being equal to that of UK industry overall. The pharmaceutical industry has generally performed relatively well in the UK market, managing to preserve incentives to innovation. This reflects the fact that UK GPs have been able to maintain their clinical freedom, as well as government recognition of the economic contribution made by the pharmaceutical industry. Current issues of interest in the UK pharmaceutical market context include the future of the PPRS, the debates over the imposition of a national formulary and generic substitution, and over parallel trade, the potential impact of managed-care protocols and computer-based prescribing on pharmaceutical expenditures, and possible political changes. PMID:10163432

  8. Selexipag: First Global Approval.

    PubMed

    Scott, Lesley J

    2016-03-01

    Selexipag (Uptravi(®)) is a highly selective, long-acting, nonprostanoid, prostacyclin receptor agonist that is being developed by Actelion Pharmaceuticals Ltd and Nippon Shinyaku. Oral selexipag is approved in the USA for the treatment of pulmonary arterial hypertension (PAH; WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH. It has subsequently been approved in Canada for the long-term treatment of PAH, and received a positive opinion in the EU for the treatment of PAH in adult patients with WHO functional class II-III. Selexipag received orphan drug designation for the treatment of PAH in Japan in 2014 and is in undergoing regulatory review in several countries for use in this indication. In the large, event-driven, phase III GRIPHON trial, selexipag reduced the risk of the primary composite endpoint of death or a complication related to PAH (whichever occurred first) by 40 % compared with placebo in patients with PAH (80 % were also receiving stable dosages of an endothelin receptor antagonist and/or a phosphodiesterase 5 inhibitor). This article summarizes the milestones in the development of selexipag leading to this first approval for PAH. PMID:26846322

  9. Herbicide and pharmaceutical relationships

    Technology Transfer Automated Retrieval System (TEKTRAN)

    For many years, virtually all pharmaceutical companies had an agrochemical division. This was partly to maximize the benefits of expensive chemical synthesis efforts by searching for many types of useful biological activities. Leads for pharmaceuticals and pesticides often overlap, in some cases l...

  10. Pharmaceutical Education in Poland

    ERIC Educational Resources Information Center

    Furmanowa, Miroslawa; Borke, Mitchell L.

    1978-01-01

    The content and organization of Poland's system of pharmaceutical education is described. Tables are presented of the subjects of the basic studies curriculum and the following areas of specialization: applied pharmacy, pharmaceutical analysis, clinical analysis, drug technology, herbal pharmacy, and bioanalysis and environmental studies. (SW)

  11. Radiation treatment of pharmaceuticals

    NASA Astrophysics Data System (ADS)

    Dám, A. M.; Gazsó, L. G.; Kaewpila, S.; Maschek, I.

    1996-03-01

    Product specific doses were calculated for pharmaceuticals to be radiation treated. Radio-pasteurization dose were determined for some heat sensitive pharmaceutical basic materials (pancreaton, neopancreatin, neopancreatin USP, duodenum extract). Using the new recommendation (ISO standards, Method 1) dose calculations were performed and radiation sterilization doses were determined for aprotinine and heparine Na.

  12. FDA pharmaceutical quality oversight.

    PubMed

    Yu, Lawrence X; Woodcock, Janet

    2015-08-01

    The launch of the Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) is a milestone in FDA's efforts to assure that quality medicines are available to the American public. As a new super-office within CDER, OPQ is strategically organized to streamline regulatory processes, advance regulatory standards, align areas of expertise, and originate surveillance of drug quality. Supporting these objectives will be an innovative and systematic approach to product quality knowledge management and informatics. Concerted strategies will bring parity to the oversight of innovator and generic drugs as well as domestic and international facilities. OPQ will promote and encourage the adoption of emerging pharmaceutical technology to enhance pharmaceutical quality and potentially reinvigorate the pharmaceutical manufacturing sector in the United States. With a motto of "One Quality Voice," OPQ embodies the closer integration of review, inspection, surveillance, policy, and research for the purpose of strengthening pharmaceutical quality on a global scale. PMID:26027494

  13. 78 FR 26301 - Approval and Promulgation of Air Quality Implementation Plans; Texas; Approval of Texas Low...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-06

    ...EPA is proposing approval of a revision to the Texas State Implementation Plan (SIP) concerning the Texas Low Emission Diesel (TxLED) Fuel rules. The revisions clarify existing definitions and provisions, revise the approval procedures for alternative diesel fuel formulations, add new registration requirements, and update the rule to reflect the current program status because the rule is now......

  14. The pharmaceutical industry: a further study in corporate power.

    PubMed

    McCraine, N; Murray, M J

    1978-01-01

    This article represents an updated version of previous research conducted on the United States pharmaceutical industry. The unstated purpose of this article is to present new findings which supplement the earlier research. This article describes three aspects of the United States pharmaceutical industry: its strategy and structure within the world market, its global expansion beyond the territorial boundaries of the United States, and its interlocking directorates with banking institutions. The thesis presented here is twofold: first, the United States pharmaceutical industry has become increasingly integrated into larger and more heterogeneous production units operating on the world market; and second, the United States pharmaceutical industry has become increasingly linked to large United States banking firms through interlocking directorates. PMID:730410

  15. Structural changes in the German pharmaceutical market: price setting mechanisms based on the early benefit evaluation.

    PubMed

    Henschke, Cornelia; Sundmacher, Leonie; Busse, Reinhard

    2013-03-01

    In the past, free price setting mechanisms in Germany led to high prices of patented pharmaceuticals and to increasing expenditures in the pharmaceutical sector. In order to control patented pharmaceutical prices and to curb increasing pharmaceutical spending, the Act for Restructuring the Pharmaceutical Market in Statutory Health Insurance (AMNOG) came into effect on 1st January 2011. In a structured dossier, pharmaceutical manufacturers have to demonstrate the additional therapeutic benefit of the newly approved pharmaceutical compared to its appropriate comparator. According to the level of additional benefit, pharmaceuticals will be subject to price negotiations between the Federal Association of Statutory Health Insurance Funds and the pharmaceutical company concerned (or assigned to a reference price group in case of no additional benefit). Therefore, the health care reform is a first step to decision making based on "value for money". The process of price setting based on early benefit evaluation has an impact on the German as well as the European pharmaceutical markets. Therefore, these structural changes in Germany are of importance for pricing decisions in many European countries both from a political point of view and for strategic planning for pharmaceutical manufacturers, which may have an effect on insured patients' access to pharmaceuticals. PMID:23339876

  16. Microcap pharmaceutical firms: linking drug pipelines to market value.

    PubMed

    Beach, Robert

    2012-01-01

    This article examines predictors of the future market value of microcap pharmaceutical companies. This is problematic since the large majority of these firms seldom report positive net income. Their value comes from the potential of a liquidity event such as occurs when a key drug is approved by the FDA. The typical scenario is one in which the company is either acquired by a larger pharmaceutical firm or enters into a joint venture with another pharmaceutical firm. Binary logistic regression is used to determine the impact of the firm's drug treatment pipeline and its investment in research and development on the firm's market cap. Using annual financial data from 2007 through 2010, this study finds that the status of the firm's drug treatment pipeline and its research and development expenses are significant predictors of the firm's future stock value relative to other microcap pharmaceutical firms. PMID:23971143

  17. Ixazomib: First Global Approval.

    PubMed

    Shirley, Matt

    2016-03-01

    Ixazomib (Ninlaro(®)) is an orally bioavailable, reversible proteasome inhibitor developed by Millennium Pharmaceuticals, Inc. (now Takeda Oncology). Ixazomib acts by binding to and inhibiting the β5 subunit of the 20S proteasome. In November 2015, the US FDA approved ixazomib for use in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. Ixazomib is under regulatory review for this indication in the EU. Phase III development of ixazomib is underway worldwide for newly-diagnosed multiple myeloma (in patients who are not eligible for stem cell transplant, or as maintenance therapy) and for relapsed or refractory systemic light chain (AL) amyloidosis. Ixazomib is also under phase I-II development for the treatment of several other haematological and non-haematological malignancies, graft-versus-host disease and lupus nephritis. This article summarizes the milestones in the development of ixazomib leading to this first approval for multiple myeloma. PMID:26846321

  18. Bacterial mutagenicity screening in the pharmaceutical industry.

    PubMed

    Escobar, P A; Kemper, R A; Tarca, J; Nicolette, J; Kenyon, M; Glowienke, S; Sawant, S G; Christensen, J; Johnson, T E; McKnight, C; Ward, G; Galloway, S M; Custer, L; Gocke, E; O'Donovan, M R; Braun, K; Snyder, R D; Mahadevan, B

    2013-01-01

    Genetic toxicity testing is used as an early surrogate for carcinogenicity testing. Genetic toxicity testing is also required by regulatory agencies to be conducted prior to initiation of first in human clinical trials and subsequent marketing for most small molecule pharmaceutical compounds. To reduce the chances of advancing mutagenic pharmaceutical candidates through the drug discovery and development processes, companies have focused on developing testing strategies to maximize hazard identification while minimizing resource expenditure due to late stage attrition. With a large number of testing options, consensus has not been reached on the best mutagenicity platform to use or on the best time to use a specific test to aid in the selection of drug candidates for development. Most companies use a process in which compounds are initially screened for mutagenicity early in drug development using tests that require only a few milligrams of compound and then follow those studies up with a more robust mutagenicity test prior to selecting a compound for full development. This review summarizes the current applications of bacterial mutagenicity assays utilized by pharmaceutical companies in early and late discovery programs. The initial impetus for this review was derived from a workshop on bacterial mutagenicity screening in the pharmaceutical industry presented at the 40th Annual Environmental Mutagen Society Meeting held in St. Louis, MO in October, 2009. However, included in this review are succinct summaries of use and interpretation of genetic toxicity assays, several mutagenicity assays that were not presented at the meeting, and updates to testing strategies resulting in current state-of the art description of best practices. In addition, here we discuss the advantages and liabilities of many broadly used mutagenicity screening platforms and strategies used by pharmaceutical companies. The sensitivity and specificity of these early mutagenicity screening

  19. Genaissance pharmaceuticals, inc.

    PubMed

    Oestreicher, Paul

    2002-03-01

    Genaissance Pharmaceuticals, Inc. (Nasdaq: GNSC) is the world leader in the discovery and use of gene variation for the development of personalized medicines. In addition, the company has established partnerships with some of the world's top biopharmaceutical companies. The company has initiated the development of its own pipeline of products -- HAP Clozapine for schizophrenia and HAP Statin for cholesterol management -- utilizing its proprietary genetic markers. The company also markets its technology and clinical development skills to the pharmaceutical industry as a complete solution for improving the development, marketing and prescribing of drugs. PMID:11972448

  20. Free trade in pharmaceuticals.

    PubMed

    Outterson, M Kevin

    2004-09-01

    Provisions in the Australia-United States Free Trade Agreement (AUSFTA) may threaten the Australian Pharmaceutical Benefits Scheme (PBS), the "gold standard" of such programs worldwide. If Australia postpones passing of the US Free Trade Agreement Implementation Bill in the Senate, there will be opportunity for broader interests in both the United States and Australia to carefully study the agreement. The provisions of AUSFTA relating to the PBS are supposed to promote transparency, but the pharmaceutical manufacturers themselves (who are demanding transparency) do not reveal the content of their submissions to the Pharmaceutical Benefits Advisory Committee, or disclose all their financial relationships with researchers and policymakers. In AUSFTA, the "public health" language of affordable prescription drugs is missing and is replaced by language supporting "pharmaceutical innovation". Debate as to whether AUSFTA will force significant changes to the PBS, including higher drug prices, is currently under way in Australia. Perhaps the appropriate target of reforms should be the excessive US drug prices, and not the economically efficient Australian drug prices. PMID:15347274

  1. Analysis of the World Bank's pharmaceutical lending.

    PubMed

    Rodríguez-Monguió, Rosa; Rovira, Joan; Seoane-Vázquez, Enrique

    2007-04-01

    This article analyzes the World Bank's lending activity on pharmaceuticals and medical products (PMP) during the fiscal years (FY) 1999-2001 by regions, borrower and supplier country, and procurement method. Data for the study derived from the World Bank Project and the Business Warehouse databases. The information included all Bank projects approved during the study period. Information for the PMP procurement contracts was extracted for the health sector components of all sector projects awarded. Contract dollar amount was aggregated by borrower and supplier countries. A total of 365 contracts of PMP for a value of US$ 364.5 million (2001 prices) were awarded. International competitive bidding was the most common procurement method used representing 46.0% of the total PMP contracts amount. Domestic providers supplied 52.5% of the PMP contracts managed by the borrower countries. Twenty-two countries accounted for 97.0% of the total PMP purchased during the period of analysis. Only a small fraction of the Bank activity was directed to the pharmaceutical sector. There is a need for more involvement of the World Bank to increase accessibility, affordability and rational use of pharmaceuticals and medical products. An evaluation of the different procurement methods and their implications on drug quality and prices should be performed. PMID:16824640

  2. Electronic Approval: Another Step toward a Paperless Office.

    ERIC Educational Resources Information Center

    Blythe, Kenneth C.; Morrison, Dennis L.

    1992-01-01

    Pennsylvania State University's award-winning electronic approval system allows administrative documents to be electronically generated, approved, and updated in the university's central database. Campus business can thus be conducted faster, less expensively, more accurately, and with greater security than with traditional paper approval…

  3. 29 CFR 1956.70 - Description of plan as approved.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 29 Labor 9 2012-07-01 2012-07-01 false Description of plan as approved. 1956.70 Section 1956.70... Islands § 1956.70 Description of plan as approved. (a) The Virgin Islands State plan was converted to a... promulgated as of June 2003, and has given assurances that it will continue to adopt and update all...

  4. 29 CFR 1956.70 - Description of plan as approved.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 29 Labor 9 2013-07-01 2013-07-01 false Description of plan as approved. 1956.70 Section 1956.70... Islands § 1956.70 Description of plan as approved. (a) The Virgin Islands State plan was converted to a... promulgated as of June 2003, and has given assurances that it will continue to adopt and update all...

  5. 29 CFR 1956.70 - Description of plan as approved.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 9 2010-07-01 2010-07-01 false Description of plan as approved. 1956.70 Section 1956.70... Islands § 1956.70 Description of plan as approved. (a) The Virgin Islands State plan was converted to a... promulgated as of June 2003, and has given assurances that it will continue to adopt and update all...

  6. Email Updates

    MedlinePlus

    ... unsubscribe. Prevent MedlinePlus emails from being marked as "spam" or "junk" To ensure that MedlinePlus email updates ... com to your email address book, adjust your spam settings, or follow the instructions from your email ...

  7. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2014-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:25673896

  8. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2014-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:24958961

  9. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2014-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:25477618

  10. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2015-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:26448675

  11. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2015-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:26405346

  12. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2015-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:25717211

  13. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2015-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:26405328

  14. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2013-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at bakerdan@wsu.edu. PMID:24421539

  15. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2013-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:24421552

  16. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2014-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:25477570

  17. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2013-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at bakerdan@wsu.edu. PMID:24421513

  18. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2015-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:26448662

  19. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2014-01-01

    Abstract This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:25477602

  20. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    2014-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:24715749

  1. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2014-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:24421565

  2. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    2014-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:24623873

  3. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals.

    PubMed

    Baker, Danial E

    2013-02-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at bakerdan@wsu.edu. PMID:24421453

  4. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals.

    PubMed

    Baker, Danial E

    2013-11-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:24421440

  5. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals.

    PubMed

    Baker, Danial E

    2013-03-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at bakerdan@wsu.edu. PMID:24421469

  6. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals.

    PubMed

    Baker, Danial E

    2013-04-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at bakerdan@wsu.edu. PMID:24421484

  7. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals.

    PubMed

    Baker, Danial E

    2013-12-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:24474838

  8. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals.

    PubMed

    Baker, Danial E

    2013-09-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at bakerdan@wsu.edu. PMID:24421539

  9. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals.

    PubMed

    Baker, Danial E

    2013-10-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:24421552

  10. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals.

    PubMed

    Baker, Danial E

    2013-06-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at bakerdan@wsu.edu. PMID:24421513

  11. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals.

    PubMed

    Baker, Danial E

    2013-07-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at bakerdan@wsu.edu. PMID:24421525

  12. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals.

    PubMed

    Baker, Danial E

    2013-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at bakerdan@wsu.edu. PMID:24421424

  13. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals.

    PubMed

    Baker, Danial E

    2013-05-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at bakerdan@wsu.edu. PMID:24421499

  14. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals.

    PubMed

    Baker, Danial E

    2014-12-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:25673896

  15. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals.

    PubMed

    Baker, Danial E

    2015-09-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:26823622

  16. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals.

    PubMed

    Baker, Danial E

    2015-10-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:26912923

  17. Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals

    PubMed Central

    Baker, Danial E.

    2013-01-01

    This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at danial.baker@wsu.edu. PMID:24474838

  18. EU pharmaceutical expenditure forecast

    PubMed Central

    Urbinati, Duccio; Rémuzat, Cécile; Kornfeld, Åsa; Vataire, Anne-Lise; Cetinsoy, Laurent; Aballéa, Samuel; Mzoughi, Olfa; Toumi, Mondher

    2014-01-01

    Background and Objectives With constant incentives for healthcare payers to contain their pharmaceutical budgets, forecasting has become critically important. Some countries have, for instance, developed pharmaceutical horizon scanning units. The objective of this project was to build a model to assess the net effect of the entrance of new patented medicinal products versus medicinal products going off-patent, with a defined forecast horizon, on selected European Union (EU) Member States’ pharmaceutical budgets. This model took into account population ageing, as well as current and future country-specific pricing, reimbursement, and market access policies (the project was performed for the European Commission; see http://ec.europa.eu/health/healthcare/key_documents/index_en.htm). Method In order to have a representative heterogeneity of EU Member States, the following countries were selected for the analysis: France, Germany, Greece, Hungary, Poland, Portugal, and the United Kingdom. A forecasting period of 5 years (2012–2016) was chosen to assess the net pharmaceutical budget impact. A model for generics and biosimilars was developed for each country. The model estimated a separate and combined effect of the direct and indirect impacts of the patent cliff. A second model, estimating the sales development and the risk of development failure, was developed for new drugs. New drugs were reviewed individually to assess their clinical potential and translate it into commercial potential. The forecast was carried out according to three perspectives (healthcare public payer, society, and manufacturer), and several types of distribution chains (retail, hospital, and combined retail and hospital). Probabilistic and deterministic sensitivity analyses were carried out. Results According to the model, all countries experienced drug budget reductions except Poland (+€41 million). Savings were expected to be the highest in the United Kingdom (−€9,367 million), France

  19. Five un-easy pieces of pharmaceutical policy reform.

    PubMed

    Rodwin, Marc A

    2013-01-01

    Improper dependencies slant policy over a drug's life span, biasing the development of new drugs, the testing and marketing approval for new drugs, and the monitoring of patient safety after drugs are marketed. This article examines five ways in which the public improperly depends on pharmaceutical firms that compromise the integrity of pharmaceutical policy. Today the public relies on pharmaceutical firms: (1) to set priorities on drug research and development; (2) to conduct clinical trials to test whether drugs are safe and effective; (3) to decide what clinical trial data to disclose to the public; (4) to monitor post marketing drug safety; (5) to supply product information to physicians and to finance continuing medical education and other professional activities. The article suggests options to overcome each of these dependencies. PMID:24088148

  20. Trade, TRIPS, and pharmaceuticals.

    PubMed

    Smith, Richard D; Correa, Carlos; Oh, Cecilia

    2009-02-21

    The World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) set global minimum standards for the protection of intellectual property, substantially increasing and expanding intellectual-property rights, and generated clear gains for the pharmaceutical industry and the developed world. The question of whether TRIPS generates gains for developing countries, in the form of increased exports, is addressed in this paper through consideration of the importance of pharmaceuticals in health-care trade, outlining the essential requirements, implications, and issues related to TRIPS, and TRIPS-plus, in which increased restrictions are imposed as part of bilateral free-trade agreements. TRIPS has not generated substantial gains for developing countries, but has further increased pharmaceutical trade in developed countries. The unequal trade between developed and developing countries (ie, exporting and importing high-value patented drugs, respectively) raises the issue of access to medicines, which is exacerbated by TRIPS-plus provisions, although many countries have not even enacted provision for TRIPS flexibilities. Therefore this paper focuses on options that are available to the health community for negotiation to their advantage under TRIPS, and within the presence of TRIPS-plus. PMID:19167054

  1. Pharmaceutical product development: A quality by design approach

    PubMed Central

    Pramod, Kannissery; Tahir, M. Abu; Charoo, Naseem A.; Ansari, Shahid H.; Ali, Javed

    2016-01-01

    The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development. PMID:27606256

  2. Pharmaceutical product development: A quality by design approach.

    PubMed

    Pramod, Kannissery; Tahir, M Abu; Charoo, Naseem A; Ansari, Shahid H; Ali, Javed

    2016-01-01

    The application of quality by design (QbD) in pharmaceutical product development is now a thrust area for the regulatory authorities and the pharmaceutical industry. International Conference on Harmonization and United States Food and Drug Administration (USFDA) emphasized the principles and applications of QbD in pharmaceutical development in their guidance for the industry. QbD attributes are addressed in question-based review, developed by USFDA for chemistry, manufacturing, and controls section of abbreviated new drug applications. QbD principles, when implemented, lead to a successful product development, subsequent prompt regulatory approval, reduce exhaustive validation burden, and significantly reduce post-approval changes. The key elements of QbD viz., target product quality profile, critical quality attributes, risk assessments, design space, control strategy, product lifecycle management, and continual improvement are discussed to understand the performance of dosage forms within design space. Design of experiments, risk assessment tools, and process analytical technology are also discussed for their role in QbD. This review underlines the importance of QbD in inculcating science-based approach in pharmaceutical product development. PMID:27606256

  3. WHO expert committee on specifications for pharmaceutical preparations. Fortieth report.

    PubMed

    2006-01-01

    This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. The report is complemented by a number of annexes. These include: a list of available International Chemical Reference Substances and International Infrared Spectra; supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms; updated supplementary guidelines on good manufacturing practices for the manufacture of herbal medicines; supplementary guidelines on good manufacturing practices for validation; good distribution practices for pharmaceutical products; a model quality assurance system for procurement agencies (recommendations for quality assurance systems focusing on prequalification of products and manufacturers, purchasing, storage and distribution of pharmaceutical products); multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability; a proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms; and additional guidance for organizations performing in vivo bioequivalence studies. PMID:16836287

  4. Drugs Approved for Leukemia

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Leukemia This page lists cancer drugs approved by the ... not listed here. Drugs Approved for Acute Lymphoblastic Leukemia (ALL) Abitrexate (Methotrexate) Arranon (Nelarabine) Asparaginase Erwinia chrysanthemi ...

  5. 10 CFR 72.248 - Safety analysis report updating.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Safety analysis report updating. 72.248 Section 72.248 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF... Approval of Spent Fuel Storage Casks § 72.248 Safety analysis report updating. (a) Each certificate...

  6. 10 CFR 72.248 - Safety analysis report updating.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Safety analysis report updating. 72.248 Section 72.248... Approval of Spent Fuel Storage Casks § 72.248 Safety analysis report updating. (a) Each certificate holder... section, the final safety analysis report (FSAR) to assure that the information included in the...

  7. 10 CFR 72.248 - Safety analysis report updating.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... Approval of Spent Fuel Storage Casks § 72.248 Safety analysis report updating. (a) Each certificate holder for a spent fuel storage cask design shall update periodically, as provided in paragraph (b) of this... Commission, in accordance with § 72.4, within 90 days after the spent fuel storage cask design has...

  8. 10 CFR 72.248 - Safety analysis report updating.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... Approval of Spent Fuel Storage Casks § 72.248 Safety analysis report updating. (a) Each certificate holder for a spent fuel storage cask design shall update periodically, as provided in paragraph (b) of this... Commission, in accordance with § 72.4, within 90 days after the spent fuel storage cask design has...

  9. 10 CFR 72.248 - Safety analysis report updating.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... Approval of Spent Fuel Storage Casks § 72.248 Safety analysis report updating. (a) Each certificate holder for a spent fuel storage cask design shall update periodically, as provided in paragraph (b) of this... Commission, in accordance with § 72.4, within 90 days after the spent fuel storage cask design has...

  10. 78 FR 4766 - Adoption of Updated EDGAR Filer Manual

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-23

    ... COMMISSION 17 CFR Parts 232, 239, 249, 269, 274 Adoption of Updated EDGAR Filer Manual AGENCY: Securities and...) Filer Manual and related rules to reflect updates to the EDGAR system. The revisions are being made...: Effective Date: January 23, 2013. The incorporation by reference of the EDGAR Filer Manual is approved...

  11. Bolaamphiphiles: A Pharmaceutical Review

    PubMed Central

    Fariya, Mayur; Jain, Ankitkumar; Dhawan, Vivek; Shah, Sanket; Nagarsenker, Mangal S.

    2014-01-01

    The field of drug discovery is ever growing and excipients play a major role in it. A novel class of amphiphiles has been discussed in the review. The review focuses on natural as well as synthetic bolaamphiphiles, their chemical structures and importantly, their ability to self assemble rendering them of great use to pharmaceutical industry. Recent reports on their ability to be used in fabrication of suitable nanosized carriers for drug as well as genes to target site, has been discussed substantially to understand the potential of bolaamphiphiles in field of drug delivery. PMID:25671179

  12. Pharmaceutical cocrystals: along the path to improved medicines.

    PubMed

    Duggirala, Naga K; Perry, Miranda L; Almarsson, Örn; Zaworotko, Michael J

    2016-01-14

    Cocrystals, a long known but understudied class of crystalline solids, have attracted interest from crystal engineers and pharmaceutical scientists in the past decade and are now an integral part of the preformulation stage of drug development. This is largely because cocrystals that contain a drug molecule, pharmaceutical cocrystals, can modify physicochemical properties without the need for covalent modification of the drug molecule. This review presents a brief history of cocrystals before addressing recent advances in design, discovery and development of pharmaceutical cocrystals that have occurred since an earlier review published in 2004. We address four aspects of cocrystals: nomenclature; design using hydrogen-bonded supramolecular synthons; methods of discovery and synthesis; development of pharmaceutical cocrystals as drug products. Cocrystals can be classified into molecular cocrystals (MCCs) that contain only neutral components (coformers) and ionic cocrystals (ICCs), which are comprised of at least one ionic coformer that is a salt. That cocrystals, especially ICCs, offer much greater diversity in terms of composition and properties than single component crystal forms and are amenable to design makes them of continuing interest. Seven recent case studies that illustrate how pharmaceutical cocrystals can improve physicochemical properties and clinical performance of drug substances, including a recently approved drug product based upon an ICC, are presented. PMID:26565650

  13. Is the United States Still Dominant in the Global Pharmaceutical Innovation Network?

    PubMed Central

    Hu, Yuanjia; Scherngell, Thomas; Man, Si Nga; Wang, Yitao

    2013-01-01

    The dramatic growth of research and development activities in the pharmaceutical sector in emerging economies raises the question of whether the United States still keeps its dominant role in the global pharmaceutical innovation landscape. This paper focuses on investigating the role of the United States in global pharmaceutical innovation, and differs from previous studies by shifting attention to a network analytic perspective to track the global distribution of pharmaceutical inventions. Our sample is composed of key patents covering all new drugs approved by the Food and Drug Administration between 1996 and 2010. The results show that the United States still dominates in the global pharmaceutical innovation network, especially when it comes to essential core inventions. However, the United States shows a slightly decreasing prominence in the networks of either total new drugs or New Molecular Entity (NME) drugs in the time period 2006–2010 as compared to previous time periods, revealed by subtle traces of network centralities. PMID:24223710

  14. Value of services provided by pharmaceutical companies: perceptions of physicians and pharmaceutical sales representatives.

    PubMed

    Gaedeke, R M; Tootelian, D H; Sanders, E E

    1999-01-01

    Pharmaceutical sales representatives (PSRs) are a key component of pharmaceutical companies' marketing strategies in that they are the link between the pharmaceutical company and the physician. PSRs provide various services in order to increase the physician's prescribing activity of their companies' products. Given the high cost of recruiting, training, and supporting a PSR, it is important for PSRs to understand the relative significance physicians ascribe to services provided. This study examined whether there is a gap in the perceptions of physicians and PSRs regarding the value of specific services provided by PSRs. Physicians and PSRs who attended medical meetings were surveyed. Results of the study indicated that there were significant differences in the perceived value between PSRs and physicians. Services which were perceived to be less important to physicians than to PSRs were new product detailing, old product detailing, providing product studies and research findings, PSRs serving as expert consultants, and recruiting physicians to participate in FDA approval drug studies. Services for which there were no significant differences of perceived value between the groups included free product samples and promotional luncheons and dinners. PMID:11066720

  15. Plus updates.

    PubMed

    Parkhouse, Richard C

    2008-01-01

    Inevitably, with an innovative and fast growing technique, improvements in hardware and refinements are ongoing. So it is with Plus. Therefore there are some relevant updates, subsequent to my article "Current Products and Practice: Tip-Edge Plus" (reprinted in the last issue of International Journalof Orthodontics by kind permission of the British Journal of Orthodontics). PMID:19263632

  16. Update '98.

    ERIC Educational Resources Information Center

    Mock, Karen R.

    1998-01-01

    Updates cases and issues previously discussed in this regular column on human rights in Canada, including racism and anti-Semitism, laws on hate crimes, hate sites on the World Wide Web, the use of the "free speech" defense by hate groups, and legal challenges to antiracist groups by individuals criticized by them. (DSK)

  17. 78 FR 50147 - 2012 Liquid Chemical Categorization Updates

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-16

    ...The Coast Guard is updating and revising regulatory tables that list liquid hazardous materials, liquefied gases, and compressed gases that have been approved for maritime transportation in bulk, and that indicate how each substance's pollution potential has been categorized. The interim rule provides new information about approved substances and their categorizations, but would not make any......

  18. Prospects for Anti-Biofilm Pharmaceuticals

    PubMed Central

    Stewart, Philip S.

    2015-01-01

    This commentary highlights several avenues currently being pursued in research labs to the development of new anti-biofilm pharmaceuticals. There is a real need for alternative therapeutic modalities for treating the persistent infections that sometimes form on implanted medical devices or compromised niches within the body. Strategies being researched include discovering new antimicrobial agents that kill microorganisms in biofilms more effectively than do existing antibiotics, designing drugs that block microbial adhesion or interfere with intercellular communication, developing chemistries to disperse biofilms, and combining agents with different mechanisms of action. Though the need is great, the pathway to commercialization of new drugs is steep. One possible streamlined approach to navigating the regulatory approval process is to repurpose old drugs, a strategy that a few groups have shown can yield agents with anti-biofilm properties. PMID:26343685

  19. Pharmaceutical excipients - quality, regulatory and biopharmaceutical considerations.

    PubMed

    Elder, David P; Kuentz, Martin; Holm, René

    2016-05-25

    Practically all medications contain excipients, which are added for the purpose of production enhancement, patient acceptability, improving stability, controlling release etc. Typically excipients are the major components of a drug product, with the active molecule only present in relatively small amounts. Historically, excipients were termed inactive components. However, as highlighted in the present paper; excipients can have an impact on the absorption, distribution, metabolism and elimination (ADME) processes of the co-administered drug, which is important information when selecting excipients for any new formulation. Further, this review also provides a description of the regulatory processes to get new excipients approved in different regions and a discussion of the recent regulatory initiatives, e.g. excipients for paediatric formulations, thereby providing points to consider for the pharmaceutical scientist when selecting excipients for a new drug formulation. PMID:26699228

  20. The Pharmaceutical Commons

    PubMed Central

    Lezaun, Javier

    2015-01-01

    In the last decade, the organization of pharmaceutical research on neglected tropical diseases has undergone transformative change. In a context of perceived “market failure,” the development of new medicines is increasingly handled by public-private partnerships. This shift toward hybrid organizational models depends on a particular form of exchange: the sharing of proprietary assets in general and of intellectual property rights in particular. This article explores the paradoxical role of private property in this new configuration of global health research and development. Rather than a tool to block potential competitors, proprietary assets function as a lever to attract others into risky collaborative ventures; instead of demarcating public and private domains, the sharing of property rights is used to increase the porosity of that boundary. This reimagination of the value of property is connected to the peculiar timescape of global health drug development, a promissory orientation to the future that takes its clearest form in the centrality of “virtual” business models and the proliferation of strategies of deferral. Drawing on the anthropological literature on inalienable possessions, we reconsider property’s traditional exclusionary role and discuss the possibility that the new pharmaceutical “commons” proclaimed by contemporary global health partnerships might be the precursor of future enclosures. PMID:25866425

  1. Mechanochemistry of ibuprofen pharmaceutical.

    PubMed

    Andini, Salvatore; Bolognese, Adele; Formisano, Domenico; Manfra, Michele; Montagnaro, Fabio; Santoro, Luciano

    2012-07-01

    In this paper mechanochemistry has been studied in view of possible application to detoxification of expired pharmaceuticals. The experiments have been carried out with a commercial medication containing ibuprofen ((RS)-2-(4-(2-methylpropyl)phenyl)propanoic acid) which has been submitted to prolonged milling up to 40h. When Al(OH)(3) is used as co-reagent, the first degradation step induced by the mechanochemical treatment is an acid-base reaction with the ibuprofen carboxylic acid group. The subsequent degradation follows a complex pathway leading to 1-(4-isobutylphenyl)ethanone, 1-isobutyl-4-vinylbenzene and 2-(4-(3-methylbutan-2-yl)phenyl)propan-1-ol after 10h milling and, in addition, 1-(4-acetylphenyl)-2-methylpropan-1-one, 1-(4-(1-hydroxy-2-methylpropyl)phenyl)ethanone and 1-(4-(2-hydroxy-2-methylpropyl)phenyl)ethanone after 40h milling. The degradation reaction path and products have been identified by means of FT-IR spectroscopy, thin layer chromatography, NMR spectroscopy, mass spectroscopy and elemental analysis. The observed ibuprofen decarboxylation makes the drug simultaneously lose both its pharmaceutical activity and toxicity. PMID:22472100

  2. New Drugs Prompt Myeloma Guidelines Update.

    PubMed

    2016-07-01

    Updates to the National Comprehensive Cancer Network's guidelines for treating multiple myeloma include new criteria for initiating treatment and an expanded menu of therapies based on recent FDA approvals. The changes extend the population of patients eligible for treatment and provide oncologists with better prognostic tools. PMID:27207892

  3. Pharmaceutical considerations of nitroglycerin

    SciTech Connect

    Yacobi, A.; Amann, A.H.; Baaske, D.M.

    1983-04-01

    During the past few years, there have been rapid changes in the pharmaceutical uses of nitroglycerin. New dosage forms and new delivery systems have become available, which have resulted in potential confusion to all concerned with the proper use of these systems. The goal of this review is to prevent confusion and to bring all the relevant information together. The various analytical techniques available for quality control of the dosage forms and for the study of the pharmacokinetics are reviewed, with the intent of enabling the reader to identify pertinent references rapidly. The interaction of nitroglycerin with packaging and plastic delivery devices is also reviewed so that the reader can make informed choices. Finally, the clinical pharmacy and pharmacokinetics are reviewed so as to bring the reader up to date in that area. After reading this article, the areas of nitroglycerin research that still need to be explored should be apparent.

  4. Pharmaceutical study of Yashadabhasma

    PubMed Central

    Bhojashettar, Santhosh; Jadar, P. G.; Rao, V. Nageswara

    2012-01-01

    Background: Rasashastra is a branch which deals with the pharmaceutics of Rasaoushadhis. Bhasmas are one among such Rasaoushadhis which are known for their low doses and fast action. A verse from Rasaratnasamuchchaya says that the bhasma prepared by using Mercury as media is of best quality. Materials and Methods: Following this principle, Yashadabhasma (Zinc calx) was prepared by subjecting it to Samanya shodhana (general purification method for all metals), Vishesha shodhana (specific putification method for Zinc), Jarana (roasting) and Marana (incineration) with Parada(Mercury) as a media under Gajaputa (classical heating system with 1000 cowdung cakes). Results and Conclusion: Yellow colored Yashadabhasma which passed all the classical bhasmaparikshas (tests for properly prepared calx) was obtained after two putas. The bhasma did not pass Nishchandratva(free from shining particles) test after 1stputa but was passed after giving it 2ndputa. PMID:23284213

  5. [Antidote update].

    PubMed

    Kiyota, Kazuya

    2016-02-01

    In Japan, several products of the antidote for poisoning have been authorized in clinical use from some recent years. For example, Hydroxcobalamin for cyanide poisoning was introduced in 2008. In 2009, Ministry of Health, Labour and Welfare invited suggestions of demand of pharmaceutical products which is high in the need in the medical care but yet unauthorized. Japanese Society for Clinical Toxicology and Japan Poison Information Center applied some candidates including methyleneblue (MB) and fomepizole, both of them were authorized in clinical market in 2015. MB is the medicine for methemoglobinemia, caused by variety of chemical products such as nitrogen oxide. Fomepizole is the antidote for methanol and ethyleneglycol, blocking alcohol dehydrogenase. PMID:26915245

  6. Pharmaceutical market access in emerging markets: concepts, components, and future

    PubMed Central

    Kumar, Anuj; Juluru, Karthaveerya; Thimmaraju, Phani Kishore; Reddy, Jayachandra; Patil, Anand

    2014-01-01

    This article intends to consolidate the concepts of pharmaceutical market access and highlight its growing importance in emerging markets. Market access has gained considerable attention worldwide as countries try to contain their escalating healthcare expenditures amidst the global economic slowdown. This has resulted in governments adopting stricter measures for new product approval. Thus, pharmaceutical companies are finding it increasingly difficult to successfully address the specific challenges posed by various government and regulatory agencies and stakeholders. There is an increasing need to establish market access functions, especially in emerging markets, where the complex, dynamic healthcare landscape confounds product approval and uptake. Moreover, emerging markets are the engines of growth today, and, thus, performing in these markets is critical for the majority of pharmaceutical companies. To address the challenges posed by regulatory agencies and diverse stakeholders, a customized market access strategy is the need of the hour. A market access framework with specific tools and tactics will help companies to plan, implement, and monitor stakeholder engagement activities. PMID:27226834

  7. Rhabdomyolysis updated

    PubMed Central

    Efstratiadis, G; Voulgaridou, A; Nikiforou, D; Kyventidis, A; Kourkouni, E; Vergoulas, G

    2007-01-01

    Rhabdomyolysis constitutes a common cause of acute renal failure and presents paramount interest. A large variety of causes with different pathogenetic mechanisms can involve skeletal muscles resulting in rhabdomyolysis with or without acute renal failure. Crush syndrome, one of the most common causes of rhabdomyolysis presents increased clinical interest, particularly in areas often involved by earthquakes, such as Greece and Turkey. Drug abusers are another sensitive group of young patients prone to rhabdomyolysis, which attracts the clinical interest of a variety of medical specialties. We herein review the evidence extracted from updated literature concerning the data related to pathogenetic mechanisms and pathophysiology as well as the management of this interesting syndrome. PMID:19582207

  8. [Pharmacovigilance update].

    PubMed

    Livio, F

    2013-01-01

    Main pharmacovigilance updates in 2012 are reviewed here. Dabigatran: elderly patients with renal failure are at higher risk of bleeding. Dual renin-angiotensin-aldosterone system blockade comprising aliskiren is harmful. Incretins: low risk of acute pancreatitis. Interaction between fusidic acid and statins: many reports of rhabdomyolysis. Interactions between boceprevir/telaprevir and antiretroviral therapies: complex, but manageable. Citalopram, ondansetron: maximum recommended doses are reduced. Atomoxetine: significant increase in blood pressure and heart rate in a fraction of exposed patients. Agomelatine: elevated liver enzymes are common. Fingolimod: bradycardia and heart blocks after first dose - stronger safety recommendations regarding use in patients with heart conditions and strengthened cardiovascular monitoring. PMID:23367709

  9. [Pharmacovigilance update].

    PubMed

    Fogarasi Szabo, Nathalie; Diezi, Léonore; Delenclos, Laurie; Renard, Delphine; Chtioui, Haithem; Rothuizen, Laura E; Buclin, Thierry; Livio, Françoise

    2015-01-14

    The main pharmacovigilance updates in 2014 are reviewed. Ivabradine: increased risk of cardiovascular death and myocardial infarction in patients with symptomatic angina treated with high dosages. Clopidogrel: rare observations of acquired hemophilia. Orlistat: may reduce the absorption of HIV antiretrovirals. Ponatinib: increased risk of arteriopathy and thrombosis. Axitinib: significant risk of heart failure (class effect). Tocilizumab: possible causal relationship with the emergence or aggravation of psoriasis. Lithium: hypercalcemia and hyperparathyroidism commonly observed. Sildenalfil: suspected causal association with melanoma, so far not proven, Methylphenidate: rare observations of priapism. St John's wort (Hypericum): reduced effectiveness of hormonal contraceptives, including implants. PMID:25799668

  10. [Pharmacovigilance update].

    PubMed

    Dao, Kim; Chtioui, Haithem; Rothuizen, Laura E; Diezi, Léonore; Prod'hom, Sylvain; Winterfeld, Ursula; Buclin, Thierry; Livio, Françoise

    2016-01-13

    The main pharmacovigilance updates in 2015are reviewed. Sofosbuvir amiodarone interaction: risk of severe bradycardia. Dasabuvir clopidogrel interaction: increased dasabuvir concentrations and potential risk of QTprolongation. SGLT2 inhibitors: risks of diabetic acidocetosis and bone fracture. Dabigatran: therapeutic drug monitoring may improve benefit-risk ratio. Ibuprofen: at higher dosage, vascular risks are comparable to coxibs. Pregabaline, gabapentine: potential for abuse and addiction. Varenicline: potentiates alcohol's effects. Codeine: contra-indicated as cough medicine under the age of twelve. Valproate: strengthened warnings on the risks of valproate use in pregnancy. Dimethylfumarate: rare observations of progressive multifocal leucoencephalopathy. Ustekinumab: rare observations of erythrodermia. PMID:26946710

  11. Mipomersen sodium: first global approval.

    PubMed

    Hair, Philip; Cameron, Fiona; McKeage, Kate

    2013-04-01

    Mipomersen sodium (Kynamro™) (henceforth mipomersen) is a second-generation antisense oligonucleotide inhibitor of apolipoprotein B-100, which is the main structural component of atherogenic lipid particles. Mipomersen is administered via subcutaneous injection and is indicated as adjunctive treatment for homozygous familial hypercholesterolaemia (HoFH). The drug was developed by Isis Pharmaceuticals, which now collaborates with Genzyme Corporation for on-going development and product marketing. Multinational phase III trials of mipomersen as adjunctive therapy were completed in patients with HoFH, severe FH, heterozygous FH (HeFH) with coronary artery disease (CAD), and in those with hypercholesterolaemia at high risk of CAD. Mipomersen 200 mg once weekly has been approved in the USA as an adjunct to lipid-lowering medications and diet in HoFH patients and is undergoing regulatory review in the EU for the same indication. Genzyme is also conducting a multinational phase III, open-label extension study to evaluate long-term treatment in HoFH and HeFH patients, as well as a multinational trial to evaluate a three-times-per-week mipomersen regimen in patients with severe FH. This article summarises the milestones in the development of once-weekly, subcutaneous mipomersen leading to this first approval. PMID:23564617

  12. 78 FR 33441 - Importer of Controlled Substances; Notice of Registration; Caraco Pharmaceutical Laboratories, LTD

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-04

    ..., 78 FR 12101, Caraco Pharmaceutical Laboratories, Ltd., 270 Prospect Plains Road, Cranbury, New Jersey... the listed controlled substance in finished dosage form for clinical trials, and research. The import... clinical trials. This authorization does not extend to the import of finished FDA approved or...

  13. Pharmaceutical Company Corruption and the Moral Crisis in Medicine.

    PubMed

    Batt, Sharon

    2016-07-01

    A much-debated series of articles in the New England Journal of Medicine in May 2015 labeled the pharmaceutical industry's critics "pharmascolds." Having followed the debate for two decades, I count myself among the scolds. The weight of the evidence overwhelmingly supports the claim that pharmaceutical policy no longer serves the public interest; the central questions now are how this happened and what to do about it. I approached three of the most recent books on the industry with these questions in mind. Deadly Medicine and Organized Crime (CRC Press, 2013), by Peter Gøtzsche, Bad Pharma (Faber & Faber, 2013), by Ben Goldacre, and Good Pharma (Palgrave MacMillan, 2015), by Donald Light and Antonio Maturo, all situate their critical assessments in high-income countries globally, depicting the problem of pharmaceuticals as too many drugs approved with too little evidence, causing too many needless deaths, and prices spiraling to heights unimaginable just a decade ago. Light and Maturo, while no less critical of the status quo than Gøtzsche and Goldacre, take a different tack: they detail the success of an alternative model for pharmaceutical research, the Mario Negri Institute in Italy, citing it as proof positive that we can indeed defy capitalism's profit imperative. PMID:27417863

  14. RESRAD update

    SciTech Connect

    Yu, C.; Cheng, J.J.; Zielen, A.J.; Jones, L.G.; LePoire, D.J.; Wang, Y.Y. ); Yuan, Y.C. ); Loureiro, C.O. . Escola de Engenharia); Wallo, A. III; Peterson, H. . Offic

    1993-01-01

    A microcomputer program called RESRAD, which implements a pathway analysis method for radiological risk assessment, was developed by Argonne National Laboratory (ANL) in 1989. This program is used to derive allowable residual concentrations of radionuclides in soil and to predict effective dose equivalents and excess cancer incidence risks incurred by an individual exposed to radioactive materials. Since its development, the RESRAD code has been adopted by DOE in Order 5400.5 for the derivation of soil cleanup criteria and dose calculations, and it has been used widely by DOE, other agencies, and their contractors. The original models used by ANL to develop RESRAD were initially developed as part of a DOE effort that began in the early 1980s and involved most of the national laboratories and DOE program offices. The RESRAD code is continuously improved and updated to incorporate comments from users and new features that ease the interaction with users and increase the code's capability and flexibility. The DOE Offices of Environmental Guidance and Environmental Restoration also provide periodic guidance regarding any significant changes to the code. The RESRAD update, Version 5.0, has substantial improvements in many aspects compared with the last version released in 1989.

  15. RESRAD update

    SciTech Connect

    Yu, C.; Cheng, J.J.; Zielen, A.J.; Jones, L.G.; LePoire, D.J.; Wang, Y.Y.; Yuan, Y.C.; Loureiro, C.O.; Wallo, A. III; Peterson, H.; H Williams, W.A.

    1993-05-01

    A microcomputer program called RESRAD, which implements a pathway analysis method for radiological risk assessment, was developed by Argonne National Laboratory (ANL) in 1989. This program is used to derive allowable residual concentrations of radionuclides in soil and to predict effective dose equivalents and excess cancer incidence risks incurred by an individual exposed to radioactive materials. Since its development, the RESRAD code has been adopted by DOE in Order 5400.5 for the derivation of soil cleanup criteria and dose calculations, and it has been used widely by DOE, other agencies, and their contractors. The original models used by ANL to develop RESRAD were initially developed as part of a DOE effort that began in the early 1980s and involved most of the national laboratories and DOE program offices. The RESRAD code is continuously improved and updated to incorporate comments from users and new features that ease the interaction with users and increase the code`s capability and flexibility. The DOE Offices of Environmental Guidance and Environmental Restoration also provide periodic guidance regarding any significant changes to the code. The RESRAD update, Version 5.0, has substantial improvements in many aspects compared with the last version released in 1989.

  16. Biricodar. Vertex Pharmaceuticals.

    PubMed

    Dey, Saibal

    2002-05-01

    Vertex is developing biricodar as a chemosensitizing agent designed to restore the effectiveness of chemotherapeutic agents in tumor multidrug resistance. By November 1998, phase II trials had commenced for biricodar, in combination with chemotherapy, for five common cancer indications: breast, ovarian, soft-tissue sarcomas, small cell lung cancer and prostate cancer. Phase II trials were ongoing in January 2002. By March 2000, Vertex was the sole developer of biricodar, as an agreement made in 1996 with BioChem Pharma (now Shire Pharmaceuticals), for the development and marketing of biricodar in Canada was terminated. Biricodar is the free base compound, which also has a citrate salt analog known as VX-710-3. Vertex has published three patents, WO-09615101, WO-09636630 and WO-09736869, disclosing derivatives of biricodar that are claimed for the treatment of multidrug resistant protein and P-glycoprotein-mediated multidrug resistant tumors. In January 2002, a Banc of America analyst report forecast that biricodar had a 30% chance of reaching the market with a launch date in the second half of 2005, with peak sales estimated at $250 million. PMID:12090559

  17. Reducing pharmaceutical risk.

    PubMed

    Spilker, B

    1998-08-01

    This article describes several types of risk encountered in drug discovery, development and marketing, as well as the overall business risks in the pharmaceutical industry. Discovery risk refers to the risk companies face if they are partly or totally dependent on discovering new drugs; many avenues are presented for companies to pursue in order to decrease discovery risk. Development risk is defined as the risk that drug discoveries that enter development will not reach the market and become commercially viable drugs. To decrease development risk, it is possible to pursue one or more of the approaches presented. Significant marketing risks for a company include that the sales forecasts will not be met, the positioning of a drug may not be correct or optimal and the sales force is not performing adequately. At the corporate level there are numerous major risks involved in pursuing the specific mission, objectives, strategies and tactics of the overall company as well as those in the functional areas. Many aspects of the company's business can be adjusted or changed to decrease corporate risk. Selected issues concerning risk include venture capital funds, the appetite for risk within a company and the influence of senior and middle level managers' personalities on risk. PMID:15616620

  18. Recognizing misleading pharmaceutical marketing online.

    PubMed

    De Freitas, Julian; Falls, Brian A; Haque, Omar S; Bursztajn, Harold J

    2014-01-01

    In light of decision-making psychology, this article details how drug marketing operates across established and novel web domains and identifies some common misleading trends and influences on prescribing and patient-initiated medication requests. The Internet has allowed pharmaceutical marketing to become more salient than ever before. Although the Internet's growth has improved the dissemination of pharmaceutical information, it has also led to the increased influence of misleading pharmaceutical marketing. Such mismarketing is of concern, especially in psychiatry, since psychotropics generate considerable revenue for drug companies. In a climate of resource-limited drug regulation and time-strapped physicians, we recommend improving both independent monitoring and consumer awareness of Internet-enabled, potentially misleading, pharmaceutical marketing influences. PMID:24986349

  19. Prioritizing pharmaceuticals in municipal wastewater

    EPA Science Inventory

    Oral presentation at SETAC North America 32nd annual meeting, describing our prioritization of active pharmaceutical ingredients (APIs), based on estimates of risks posed by API residues originating from municipal wastewater. Goals of this project include prioritization of APIs f...

  20. Does Increased Spending on Pharmaceutical Marketing Inhibit Pioneering Innovation?

    PubMed

    Arnold, Denis G; Troyer, Jennifer L

    2016-04-01

    The pharmaceutical industry has been criticized for developing and aggressively marketing drugs that do not provide significant health benefits relative to existing drugs but retain the benefits of patent protection. Critics argue that drug marketing increases health care expenditures and provides a disincentive for pioneering drug innovation. However, evidence that marketing expenditures have any relationship to new drug approvals has been anecdotal. We hypothesized that, at publicly traded pharmaceutical firms, increased marketing expenditures will result in a reduced volume of pioneering new drugs in comparison to less innovative new drugs. We also hypothesized that additional research and development spending will result in an increased volume of pioneering new drugs in comparison to less innovative drugs. Results confirm our hypotheses. Specific policy recommendations for altering firms' incentives for the development of pioneering drugs are provided. PMID:26732315

  1. Clinical pharmacogenomics: applications in pharmaceutical R&D.

    PubMed

    Norton, R M.

    2001-02-01

    Within the pharmaceutical industry, the application of clinical pharmacogenomics promises to enhance the discovery of drug response markers, reduce the size and expense of clinical drug trials and provide a new tool for addressing regulatory approval issues. Today, pharmacogenomics is primarily applied early in clinical drug development by prospective genotyping in Phase I trials, to ensure that a subject population is representative with respect to drug metabolism phenotypes. The banking of genetic material from later stage trials for retrospective studies on drug response is becoming more frequent, but is not yet standard in the industry. This article provides an overview of the driving forces that are encouraging pharmacogenomic strategy development in the pharmaceutical industry, and the significance of polymorphisms in drug metabolizing enzymes (DMEs) and target proteins. PMID:11173265

  2. Quality investigation of hydroxyprogesterone caproate active pharmaceutical ingredient and injection

    PubMed Central

    Chollet, John L.; Jozwiakowski, Michael J.

    2012-01-01

    The purpose of this study was to investigate the quality of hydroxyprogesterone caproate (HPC) active pharmaceutical ingredient (API) sources that may be used by compounding pharmacies, compared to the FDA-approved source of the API; and to investigate the quality of HPC injection samples obtained from compounding pharmacies in the US, compared to the FDA-approved product (Makena®). Samples of API were obtained from every source confirmed to be an original manufacturer of the drug for human use, which were all companies in China that were not registered with FDA. Eight of the ten API samples (80%) did not meet the impurity specifications required by FDA for the API used in the approved product. One API sample was found to not be HPC at all; additional laboratory testing showed that it was glucose. Thirty samples of HPC injection obtained from com pounding pharmacies throughout the US were also tested, and eight of these samples (27%) failed to meet the potency requirement listed in the USP monograph for HPC injection and/or the HPLC assay. Sixteen of the thirty injection samples (53%) exceeded the impurity limit setforthe FDA-approved drug product. These results confirm the inconsistency of compounded HPC Injections and suggest that the risk-benefit ratio of using an unapproved compounded preparation, when an FDA-approved drug product is available, is not favorable. PMID:22329865

  3. 77 FR 66945 - Approval and Promulgation of Air Quality Implementation Plans; New Hampshire; Reasonably...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-08

    ... AGENCY 40 CFR Part 52 Approval and Promulgation of Air Quality Implementation Plans; New Hampshire; Reasonably Available Control Technology Update To Address Control Techniques Guidelines Issued in 2006, 2007... revision establishes Reasonably Available Control Technology (RACT) for several categories of...

  4. Exploration Update

    NASA Technical Reports Server (NTRS)

    2006-01-01

    Delores Beasley, NASA Public Affairs, introduces the panel who consist of: Scott "Doc" Horowitz, Associate Administrator of Exploration Systems from NASA Headquarters; Jeff Henley, Constellation Program Manager from NASA Johnson Space Flight Center; and Steve Cook, Manager Exploration Launch Office at NASA Marshall Space Flight Center. Scott Horowitz presents a short video entitled, "Ares Launching the Future". He further explains how NASA personnel came up with the name of Ares and where the name Ares was derived. Jeff Henley, updates the Constellation program and Steve Cook presents two slide presentations detailing the Ares l crew launch vehicle and Ares 5 cargo launch vehicle. A short question and answer period from the news media follows.

  5. [Pharmacovigilance update].

    PubMed

    Diezi, Léonore; Renard, Delphine; Rothuizen, Laura E; Livio, Françoise

    2014-01-15

    The main pharmacovigilance updates in 2013 are reviewed. Nitrofurantoin: lower efficacy and an increased risk of adverse events when creatinine clearance is below 60 ml/min. Dabigatran: contraindicated in patients with mechanical heart valves. Azithromycin: QT prolongation and increased risk of death. Zolpidem: towards a lower dosage. Roflumilast: avoid in patients known or at risk for mood disorders. Retigabine: indication restricted to last-line use and new monitoring requirements after reports of pigment changes in retina and other tissues. Telaprevir and rituximab: severe mucocutaneous reactions. Fingolimod: rare cases of progressive multifocal leucoencephalopathy. Tolvaptan: potential for hepatotoxicity. Nicotinic acid/laropiprant: suspension of marketing authorization as benefits no longer outweigh risks. PMID:24558915

  6. Aripiprazole (Otsuka Pharmaceutical Co).

    PubMed

    Ozdemir, Vural; Fourie, Jeanne; Ozdener, Fatih

    2002-01-01

    Otsuka Pharmaceuticals in collaboration with Bristol-Myers Squibb is developing aripiprazole, a dual dopamine autoreceptor agonist and postsynaptic D2 receptor antagonist, for the potential treatment of psychoses including schizophrenia [281327], [340364]. A regulatory filing for schizophrenia in the US was submitted at the end of 2001 [340364]. The compound entered phase III trials in Japan in 1995 [192966]. Although presynaptic dopamine autoreceptor agonists may be efficacious in the treatment of schizophrenia, they may also potentially increase the risk for exacerbation of psychosis through stimulation of postsynaptic dopaminergic receptors [245791], [350478], [350479]. However, earlier neuropharmacology studies have shown that aripiprazole can act as a presynaptic D2 agonist while displaying an antagonistic effect at the postsynaptic D2 receptors [281327], [337126], [350479], [424587], [424588]. In animal models, aripiprazole inhibits the apomorphine-induced stereotypy, without causing catalepsy [281327], [337126]. Moreover, in contrast to classical antipsychotics that produce disabling movement disorders, aripiprazole does not cause an upregulation of D2 receptors or an increase in expression of the c-fos mRNA in the striatum, in agreement with the low risk for extrapyramidal side effects (EPS) during aripiprazole treatment [245781], [262096], [350481], [350483]. Collectively, aripiprazole is an important atypical antipsychotic candidate with a favorable safety profile. Moreover, the mechanism of action of aripiprazole differentiates it from both typical and atypical antipsychotics and hence, may provide important leads for pharmacotherapy of schizophrenia and other psychotic disorders. In January 2000, Lehman Brothers predicted peak sales of aripiprazole could reach US $500 million [357788]. In February 2001, Credit Suisse First Boston predicted sales of US $403 million in 2005 [399484]. PMID:12054061

  7. A vision of the pharmaceutical industry.

    PubMed

    Muñio, S

    1998-01-01

    As the financial resources available for looking after the health of an aging population are limited, generic drugs (drugs that are no longer covered by a patent and marketed at a lower price) have come to be used in western countries as a means for meeting growing demand while leaving resources in the health budget for new drugs. In Spain, a law on product patents was introduced in 1992, which is much later than in other countries, and created difficulties in the definition and procedure for gaining approval for generic drugs. Circular 3/97 from the Ministry of Health finally resolved these issues. In this circular, generic pharmaceutical products (GPPs) are clearly defined and identified with a positive commitment towards guaranteeing the ability to interchange original drugs for other cheaper generic products and towards clarifying the Spanish vade mecum. The position of the pharmaceutical industry on generic drugs varies widely and consequently, it is impossible to make a general statement on the view of the industry. However, the commitment of Novartis, given the issues described above and in line with the company's global strategy, is to offer innovation and services to society. This is perfectly compatible with offering health professionals both innovative drugs and generic drugs of a high quality at a lower price, given that registering genetics requires less investment in research and development. In any case, GPPs face an uncertain future in Spain and market forecasts also differ widely, ranging from 15 billion to 80 billion pesetas in the year 2000. It will be necessary to get doctors and pharmacists positively involved, to set up fast structural measures, and to avoid rejection by patients through successful information and marketing. PMID:9800720

  8. Innovation in the pharmaceutical industry: New estimates of R&D costs.

    PubMed

    DiMasi, Joseph A; Grabowski, Henry G; Hansen, Ronald W

    2016-05-01

    The research and development costs of 106 randomly selected new drugs were obtained from a survey of 10 pharmaceutical firms. These data were used to estimate the average pre-tax cost of new drug and biologics development. The costs of compounds abandoned during testing were linked to the costs of compounds that obtained marketing approval. The estimated average out-of-pocket cost per approved new compound is $1395 million (2013 dollars). Capitalizing out-of-pocket costs to the point of marketing approval at a real discount rate of 10.5% yields a total pre-approval cost estimate of $2558 million (2013 dollars). When compared to the results of the previous study in this series, total capitalized costs were shown to have increased at an annual rate of 8.5% above general price inflation. Adding an estimate of post-approval R&D costs increases the cost estimate to $2870 million (2013 dollars). PMID:26928437

  9. 78 FR 46977 - Generic Drug User Fee-Abbreviated New Drug Application, Prior Approval Supplement, Drug Master...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

    ...The Food and Drug Administration (FDA) is announcing the rate for the abbreviated new drug application (ANDA), prior approval supplement to an approved ANDA (PAS), drug master file (DMF), generic drug active pharmaceutical ingredient (API), and finished dosage form (FDF) facilities user fees related to the Generic Drug User Fee Program for fiscal year (FY) 2014. The Federal Food, Drug, and......

  10. ISIS-3521. Isis Pharmaceuticals.

    PubMed

    Li, K; Zhang, J

    2001-10-01

    ISIS-3521 is a 20-mer antisense phosphorothioate oligonucleotide PKCa expression inhibitor, under development by Isis (formerly in collaboration with Novartis) for the potential treatment of solid tumors that are refractory to, or recurrent with, standard treatment regimens [175741]. In November 1999, Novartis announced that it would end its codevelopment of ISIS-3521 [348221], [348222]. In August 2001, Eli Lilly in-licensed ISIS-3521 [420062]. In October 2000, phase III trials of ISIS-3521, in combination with carboplatin and paclitaxel, were initiated for the treatment of non-small cell lung cancer (NSCLC) [386128]. The FDA granted ISIS-3521 Fast Track review status for NSCLC in November 2000 [388930]. In April 2001, Bear Sterns & Co predicted US approval of ISIS-3521 in 2002 [411081]. In August 2001, Eli Lilly and Isis entered into a four-year strategic alliance that includes ISIS-3521. For the license of ISIS-3521, Isis will receive $25 million in upfront fees and will be reimbursed for remaining phase III development and registration costs [420062]. PMID:11890365

  11. Virtual pharmaceutical companies: collaborating flexibly in pharmaceutical development.

    PubMed

    Forster, Simon P; Stegmaier, Julia; Spycher, Rene; Seeger, Stefan

    2014-03-01

    Research and development (R&D) collaborations represent one approach chosen by the pharmaceutical industry to tackle current challenges posed by declining internal R&D success rates and fading of the blockbuster model. In recent years, a flexible concept to collaborate in R&D has emerged: virtual pharmaceutical companies (VPCs). These differ from other R&D companies, such as biotech start-ups, collaborating with big pharmaceutical companies, because they solely comprise experienced teams of managers. VPCs have only been described anecdotally in literature. Thus, we present here the characteristics of a VPC and suggest how big pharma can leverage the concept of VPCs by introducing five possible modes of collaboration. We find that one mode, investing, is particularly promising for big pharma. PMID:24291787

  12. Regulatory approval pathways for anticancer drugs in Japan, the EU and the US.

    PubMed

    Nagai, Sumimasa; Ozawa, Keiya

    2016-07-01

    The Pharmaceuticals and Medical Devices Agency and the Ministry of Health, Labour and Welfare in Japan and the US Food and Drug Administration are responsible for reviewing applications and approving drugs, medical devices, and regenerative medicines. In the EU, the European Medicines Agency is responsible for the centralized authorization procedure of medicines including oncologic drugs. In this review, we discuss general pathways for the marketing authorization of oncologic drugs and other drugs in Japan, the EU, and the US. There are still unmet medical needs in oncology, whereas scientific innovation and clinical development in oncology are rapid and active, suggesting a reasonable scope for new regulatory schemes for expedited review. Because regulatory schemes are also evolving rapidly, clinicians and academic researchers may have difficulty following the updated regulations in other regions as well as those in their own countries. However, keeping current with new regulations is important for the conduct of translational research and clinical development of new therapeutic products efficiently. This review is intended to help an international audience better understand the essence of the regulatory frameworks for the marketing authorization of oncologic drugs in Japan, the EU, and the US. PMID:27084259

  13. Activities update

    NASA Astrophysics Data System (ADS)

    Smith, Gerald A.

    1994-07-01

    The present report is an update on activities for the second year of funding. Research leading to a detailed characterization of antiproton annihilation in nuclei has resulted in a published analysis of fast deuteron production from carbon and uranium targets. This follows previously reported work and publications by our group on gamma-ray, neutral and charged pion, proton, and neutron production. The deuteron measurements are important to our SHIVA Star antiproton- catalyzed microfission experiment at the Phillips Laboratory, Kirtland AFB, in that they help constrain theoretical models of light nuclei production and subsequent energy deposition in the target. Work continues at SHIVA Star on working fluid formation and target compression for the microfission experiment. Excellent progress has been made, both theoretically and experimentally, on these important aspects of the experiment. The Penn State group, working in collaboration with Los Alamos National Laboratory physicists, trapped and held up to 721,000 antiprotons per beam injection pulse from the LEAR accelerator during July, 1993. This was a crucial step to the ultimate goal of transferring large numbers of antiprotons to the Phillips Laboratory for the antiproton-catalyzed microfission experiment.

  14. Ebola Update.

    PubMed

    O'Keefe, Louise C

    2016-01-01

    The Ebola virus disease first appeared in 1976 in the Sudan and the Democratic Republic of Congo. The most recent outbreak occurred in West Africa in March 2014 and quickly spread in surrounding countries. Ebola spreads through direct contact with the body fluids of an infected individual. The incubation period for Ebola is 2 to 21 days. Individuals are infectious when symptomatic. Identifying individuals at high risk for Ebola in the United States includes early recognition of symptoms and a history of travel to an Ebola-affected area. Multiple diagnostic tests exist and should include a complete blood count and a comprehensive metabolic profile. Standard, contact, and droplet precautions are advised when taking care of patients with Ebola. Appropriate personal protective equipment as recommended by the Centers for Disease Control and Prevention should be worn. No vaccine or antiviral drug has been approved, but vaccine trials are under way. Occupational health nurses play a key role in educating employees about this disease. PMID:26419541

  15. Reprivatizing pharmaceutical supplies in Africa.

    PubMed

    Turshen, M

    2001-01-01

    Perhaps no part of the health system is as imperiled by neoliberal economic reforms as the public drug sector. The national bill for pharmaceuticals can claim one-third of a developing country's annual health budget. This article describes the essential drugs program created by WHO in the 1980s to protect financially reduced ministries of health from the high prices charged by multinational pharmaceutical companies. It describes the backlash from the World Bank and UNICEF, which launched the Bamako Initiative and other community financing schemes and revolving drug plans in which individuals, families or community groups buy drugs above the wholesale purchase price; clinics use the proceeds to maintain drug supplies and subsidize other health services. When this plan failed, the Bank proposed outright privatization of drug purchase and supply, returning power to the multinational suppliers. The article ends with a consideration of patents and the new intellectual property rights as they pertain to pharmaceutical production in Africa. PMID:11469153

  16. Chemistry in the Pharmaceutical Industry

    NASA Astrophysics Data System (ADS)

    Poindexter, Graham S.; Pendri, Yadagiri; Snyder, Lawrence B.; Yevich, Joseph P.; Deshpande, Milind

    This chapter will discuss the role of chemistry within the pharmaceutical industry. Although the focus will be upon the industry within the United States, much of the discussion is equally relevant to pharmaceutical companies based in other first world nations such as Japan and those in Europe. The major objective of the pharmaceutical industry is the discovery, development, and marketing of efficacious and safe drugs for the treatment of human disease. Of course drug companies do not exist as altruistic, charitable organizations but like other share-holder owned corporations within our capitalistic society must achieve profits in order to remain viable and competitive. Thus, there exists a conundrum between the dual goals of enhancing the quality and duration of human life and that of increasing stock-holder equity. Much has been written and spoken in the lay media about the high prices of prescription drugs and the hardships this places upon the elderly and others of limited income.

  17. 78 FR 18364 - Electronic Prescriptions for Controlled Substances Notice of Approved Certification Process

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-26

    ... FR 16236-16319, and became effective on June 1, 2010. Update Certifying Organizations With a... posted on DEA's Web site. 75 FR 16243 (March 31, 2010). On January 18, 2013, DEA approved the... biometrics subsystem, including its interfaces. 77 FR 45688 (August 1, 2012). This approval for...

  18. 75 FR 8249 - Approval and Promulgation of Air Quality Implementation Plans; Virginia; Opacity Source...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-24

    ...EPA is taking direct final action to approve revisions to the Commonwealth of Virginia State Implementation Plan (SIP). The revisions update methods for determining compliance with opacity standards for existing, new and modified stationary sources. EPA is approving these revisions in accordance with the requirements of the Clean Air Act...

  19. 77 FR 40394 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-09

    ... Release No. 67021 (May 18, 2012), 77 FR 31060 (May 24, 2012). II. Description OCC is updating the... COMMISSION Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule... to approve a proposed rule change of a self-regulatory organization if it finds that such...

  20. 77 FR 35917 - Approval and Promulgation of Implementation Plans; Revisions to the Georgia State Implementation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-15

    ... AGENCY 40 CFR Part 52 Approval and Promulgation of Implementation Plans; Revisions to the Georgia State... approve a State Implementation Plan (SIP) revision submitted by the State of Georgia, through the... to update the transportation conformity criteria and procedures in the Georgia SIP. This action...

  1. 28 CFR 58.34 - Minimum requirements to become and remain approved providers relating to fees.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... income is less than 150 percent of the poverty guidelines updated periodically in the Federal Register by... instructional course is presumed to be reasonable and a provider need not obtain prior approval of the United... to be reasonable and a provider must obtain prior approval from the United States Trustee to...

  2. 28 CFR 58.34 - Minimum requirements to become and remain approved providers relating to fees.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... income is less than 150 percent of the poverty guidelines updated periodically in the Federal Register by... instructional course is presumed to be reasonable and a provider need not obtain prior approval of the United... to be reasonable and a provider must obtain prior approval from the United States Trustee to...

  3. 78 FR 36560 - 30-Day Notice of Proposed Information Collection: FHA Lender Approval, Annual Renewal, Periodic...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-18

    ... URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: FHA Lender Approval, Annual Renewal...: Colette Pollard, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th... Title of Information Collection: FHA Lender Approval, Annual Renewal, Periodic Updates and...

  4. 78 FR 17937 - Notice of Proposed Information Collection for Public Comment; FHA Lender Approval, Annual Renewal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-25

    ... URBAN DEVELOPMENT Notice of Proposed Information Collection for Public Comment; FHA Lender Approval, Annual Renewal, Periodic Updates and Noncompliance Reporting by FHA Approved Lenders AGENCY: Office of...: Reports Liaison Officer, Department of Housing and Urban Development, 451 7th Street SW., Washington,...

  5. 76 FR 51049 - Notice of Submission of Proposed Information Collection to OMB; FHA Lender Approval, Annual...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-17

    ...The proposed information collection requirement described below has been submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal. This information is required for: (1) FHA Lender Approval; (2) Annual renewal of each FHA Lender's Approval; (3) Updates to a FHA Lender's......

  6. 75 FR 12251 - Notice of Proposed Information Collection for Public Comment; FHA Lender Approval, Annual Renewal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-15

    ... URBAN DEVELOPMENT Notice of Proposed Information Collection for Public Comment; FHA Lender Approval, Annual Renewal, Periodic Updates and Noncompliance Reporting by FHA Approved Lenders AGENCY: Office of... Housing and Urban Development, 451 7th Street, SW., Washington, DC 20410; e-mail...

  7. 76 FR 34091 - Notice of Proposed Information Collection for Public Comment; FHA Lender Approval, Annual Renewal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-10

    ... URBAN DEVELOPMENT Notice of Proposed Information Collection for Public Comment; FHA Lender Approval, Annual Renewal, Periodic Updates and Noncompliance Reporting by FHA Approved Lenders AGENCY: Office of...: Reports Liaison Officer, Department of Housing and Urban Development, 451 7th Street, SW., Washington,...

  8. 77 FR 63323 - Notice of Proposed Information Collection for Public Comment; FHA Lender Approval, Annual Renewal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-16

    ... URBAN DEVELOPMENT Notice of Proposed Information Collection for Public Comment; FHA Lender Approval, Annual Renewal, Periodic Updates and Noncompliance Reporting by FHA Approved Lenders AGENCY: Office of...: Reports Liaison Officer, Department of Housing and Urban Development, 451 7th Street SW., Washington,...

  9. 75 FR 78602 - Approval and Promulgation of Air Quality Implementation Plans; Minnesota

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-16

    ...EPA is approving a request submitted by the Minnesota Pollution Control Agency (MPCA) on May 7, 2010, to revise the Minnesota State Implementation Plan (SIP) for particulate matter less than 10 microns (PM10). The approval revises the Minnesota SIP by updating information for the Metropolitan Council Environmental Services (MCES) Metropolitan Wastewater Treatment Plant located in......

  10. 75 FR 8292 - Approval and Promulgation of Air Quality Implementation Plans; Virginia; Opacity Source...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-24

    ...EPA proposes to approve the State Implementation Plan (SIP) revision submitted by the Commonwealth of Virginia for the purpose of updating methods for determining compliance with opacity standards for existing, new and modified stationary sources in Virginia. In the Final Rules section of this Federal Register, EPA is approving the State's SIP submittal as a direct final rule without prior......

  11. 78 FR 70516 - Approval and Promulgation of Implementation Plans; North Carolina: Non-Interference Demonstration...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-26

    ...EPA is proposing to approve the State of North Carolina's April 12, 2013, State Implementation Plan (SIP) revision associated with the currently approved maintenance plan addressing the 1997 8-hour national ambient air quality standards (NAAQS) for the Greensboro/ Winston-Salem/High Point (Triad) Area. Specifically, North Carolina's revision, including updated modeling, shows that the Triad......

  12. 75 FR 36301 - Review and Approval of Projects

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-25

    ... final at 71 FR 78570, December 29, 2006, updating and expanding the range of projects subject to... COMMISSION 18 CFR Parts 806 and 808 Review and Approval of Projects AGENCY: Susquehanna River Basin... proposed rules that would amend the project review regulations of the Susquehanna River Basin...

  13. 76 FR 8989 - Federal Acquisition Regulation; Updated Financial Accounting Standards Board Accounting References

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-16

    ... any information collection requirements that require the approval of the Office of Management and... 9000-AM00 Federal Acquisition Regulation; Updated Financial Accounting Standards Board Accounting... standards owing to the Financial Accounting Standards Board's (FASB's) Accounting Standards...

  14. Proposed Plan for Adopting Updated Range Reference Atmospheres

    NASA Technical Reports Server (NTRS)

    Keller, Vernon; Burns, Lee

    2004-01-01

    The Terrestrial and Planetary Environments Team at Marshall Space Flight Center (MSFC) proposes to facilitate validation, documentation, and adoption of updated Range Reference Atmospheres (RRAs). This viewgraph presentation describes the plan, focusing on seven tasks: 1) Document data sources; 2) Document analytical models; 3) Document data processing procedures; 4) Compare updates to 1983 versions; 5) Compile written documentation; 6) Obtain approval for final volumes; 7) Publish new RRA datasets/documents.

  15. Chapter A5. Section 6.1.F. Wastewater, Pharmaceutical, and Antibiotic Compounds

    USGS Publications Warehouse

    Lewis, Michael Edward; Zaugg, Steven D.

    2003-01-01

    The USGS differentiates between samples collected for analysis of wastewater compounds and those collected for analysis of pharmaceutical and antibiotic compounds, based on the analytical schedule for the laboratory method. Currently, only the wastewater laboratory method for field-filtered samples (SH1433) is an approved, routine (production) method. (The unfiltered wastewater method LC 8033 also is available but requires a proposal for custom analysis.) At this time, analysis of samples for pharmaceutical and antibiotic compounds is confined to research studies and is available only on a custom basis.

  16. Current Pharmaceutical Treatments and Alternative Therapies of Parkinson's Disease.

    PubMed

    Dong, Jie; Cui, Yanhua; Li, Song; Le, Weidong

    2016-01-01

    Over the decades, pharmaceutical treatments, particularly dopaminergic (DAergic) drugs have been considered as the main therapy against motor symptoms of Parkinson's disease (PD). It is proposed that DAergic drugs in combination with other medications, such as monoamine oxidase type B inhibitors, catechol-O-methyl transferase inhibitors, anticholinergics and other newly developed non-DAergic drugs can make a better control of motor symptoms or alleviate levodopa-induced motor complications. Moreover, non-motor symptoms of PD, such as cognitive, neuropsychiatric, sleep, autonomic and sensory disturbances caused by intrinsic PD pathology or drug-induced side effects, are gaining increasing attention and urgently need to be taken care of due to their impact on quality of life. Currently, neuroprotective therapies have been investigated extensively in pre-clinical studies, and some of them have been subjected to clinical trials. Furthermore, non-pharmaceutical treatments, including deep brain stimulation (DBS), gene therapy, cell replacement therapy and some complementary managements, such as Tai chi, Yoga, traditional herbs and molecular targeted therapies have also been considered as effective alternative therapies to classical pharmaceutics. This review will provide us updated information regarding the current drugs and non-drugs therapies for PD. PMID:26585523

  17. Homochiral drugs: a demanding tendency of the pharmaceutical industry.

    PubMed

    Núñez, María C; García-Rubiño, M Eugenia; Conejo-García, Ana; Cruz-López, Olga; Kimatrai, María; Gallo, Miguel A; Espinosa, Antonio; Campos, Joaquín M

    2009-01-01

    The issue of drug chirality is now a major theme in the design and development of new drugs, underpinned by a new understanding of the role of molecular recognition in many pharmacologically relevant events. In general, three methods are utilized for the production of a chiral drug: the chiral pool, separation of racemates, and asymmetric synthesis. Although the use of chiral drugs predates modern medicine, only since the 1980's has there been a significant increase in the development of chiral pharmaceutical drugs. An important commercial reason is that as patents on racemic drugs expire, pharmaceutical companies have the opportunity to extend patent coverage through development of the chiral switch enantiomers with desired bioactivity. Stimulated by the new policy statements issued by the regulatory agencies, the pharmaceutical industry has systematically begun to develop chiral drugs in enantiometrically enriched pure forms. This new trend has caused a tremendous change in the industrial small- and large-scale production to enantiomerically pure drugs, leading to the revisiting and updating of old technologies, and to the development of new methodologies of their large-scale preparation (as the use of stereoselective syntheses and biocatalyzed reactions). The final decision whether a given chiral drug will be marketed in an enantiomerically pure form, or as a racemic mixture of both enantiomers, will be made weighing all the medical, financial and social proficiencies of one or other form. The kinetic, pharmacological and toxicological properties of individual enantiomers need to be characterized, independently of a final decision. PMID:19519381

  18. Endocrine-Active Pharmaceuticals: An Environmental Concern?

    EPA Science Inventory

    Recently, there has been growing interest in pharmaceuticals that are specifically designed to have endocrine activity, such as the estrogens used in birth control pills, exerting unintended effects on fish and other aquatic organisms. These pharmaceuticals may not be persistent...

  19. More New Medication Approvals.

    PubMed

    Turkoski, Beatrice B

    2016-01-01

    In the past year, the Federal Drug Administration (FDA) approved many new drugs for treating a wide variety of patient health problems. In a previous article, examples of approvals for the early part of last year were addressed. In this article, selected new FDA approvals through January 2016 are discussed. Nurses who are knowledgeable and informed about these new drugs will be able to answer patients' questions, clarify misunderstandings, and reduce the potential for medication misadventures. PMID:27441881

  20. Pharmaceutical care in smoking cessation.

    PubMed

    Marín Armero, Alicia; Calleja Hernandez, Miguel A; Perez-Vicente, Sabina; Martinez-Martinez, Fernando

    2015-01-01

    As a determining factor in various diseases and the leading known cause of preventable mortality and morbidity, tobacco use is the number one public health problem in developed countries. Facing this health problem requires authorities and health professionals to promote, via specific programs, health campaigns that improve patients' access to smoking cessation services. Pharmaceutical care has a number of specific characteristics that enable the pharmacist, as a health professional, to play an active role in dealing with smoking and deliver positive smoking cessation interventions. The objectives of the study were to assess the efficacy of a smoking cessation campaign carried out at a pharmaceutical care center and to evaluate the effects of pharmaceutical care on patients who decide to try to stop smoking. The methodology was an open, analytical, pre-post intervention, quasi-experimental clinical study performed with one patient cohort. The results of the study were that the promotional campaign for the smoking cessation program increased the number of patients from one to 22, and after 12 months into the study, 43.48% of the total number of patients achieved total smoking cessation. We can conclude that advertising of a smoking cessation program in a pharmacy increases the number of patients who use the pharmacy's smoking cessation services, and pharmaceutical care is an effective means of achieving smoking cessation. PMID:25678779

  1. Electron microscopy of pharmaceutical systems.

    PubMed

    Klang, Victoria; Valenta, Claudia; Matsko, Nadejda B

    2013-01-01

    During the last decades, the focus of research in pharmaceutical technology has steadily shifted towards the development and optimisation of nano-scale drug delivery systems. As a result, electron microscopic methods are increasingly employed for the characterisation of pharmaceutical systems such as nanoparticles and microparticles, nanoemulsions, microemulsions, solid lipid nanoparticles, different types of vesicles, nanofibres and many more. Knowledge of the basic properties of these systems is essential for an adequate microscopic analysis. Classical transmission and scanning electron microscopic techniques frequently have to be adapted for an accurate analysis of formulation morphology, especially in case of hydrated colloidal systems. Specific techniques such as environmental scanning microscopy or cryo preparation are required for their investigation. Analytical electron microscopic techniques such as electron energy-loss spectroscopy or energy-dispersive X-ray spectroscopy are additional assets to determine the elemental composition of the systems, but are not yet standard tools in pharmaceutical research. This review provides an overview of pharmaceutical systems of interest in current research and strategies for their successful electron microscopic analysis. Advantages and limitations of the different methodological approaches are discussed and recent findings of interest are presented. PMID:22921788

  2. Pharmaceutical crystallization with nanocellulose organogels.

    PubMed

    Ruiz-Palomero, Celia; Kennedy, Stuart R; Soriano, M Laura; Jones, Christopher D; Valcárcel, Miguel; Steed, Jonathan W

    2016-06-14

    Carboxylated nanocellulose forms organogels at 0.3 wt% in the presence of a cationic surfactant. The resulting gels can be used as novel crystallization media for pharmaceutical solid form control, resulting in isolation a new sulfapyridine solvate, morphology modification and crystallization of an octadecylammonium salt of sulfamethoxazole. PMID:27168091

  3. Changing tides: Adaptive monitoring, assessment, and management of pharmaceutical hazards in the environment through time.

    PubMed

    Gaw, Sally; Brooks, Bryan W

    2016-04-01

    Pharmaceuticals are ubiquitous contaminants in aquatic ecosystems. Adaptive monitoring, assessment, and management programs will be required to reduce the environmental hazards of pharmaceuticals of concern. Potentially underappreciated factors that drive the environmental dose of pharmaceuticals include regulatory approvals, marketing campaigns, pharmaceutical subsidies and reimbursement schemes, and societal acceptance. Sales data for 5 common antidepressants (duloxetine [Cymbalta], escitalopram [Lexapro], venlafaxine [Effexor], bupropion [Wellbutrin], and sertraline [Zoloft]) in the United States from 2004 to 2008 were modeled to explore how environmental hazards in aquatic ecosystems changed after patents were obtained or expired. Therapeutic hazard ratios for Effexor and Lexapro did not exceed 1; however, the therapeutic hazard ratio for Zoloft declined whereas the therapeutic hazard ratio for Cymbalta increased as a function of patent protection and sale patterns. These changes in therapeutic hazard ratios highlight the importance of considering current and future drivers of pharmaceutical use when prioritizing pharmaceuticals for water quality monitoring programs. When urban systems receiving discharges of environmental contaminants are examined, water quality efforts should identify, prioritize, and select target analytes presently in commerce for effluent monitoring and surveillance. PMID:26412644

  4. Position and enforcement practice of the People's Republic of China's pharmaceutical data exclusivity protection.

    PubMed

    Li, Na; Yu, Xiang; Pecht, Michael

    2016-01-01

    The concept of pharmaceutical data exclusivity protection comes from the West. The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) establishes the basic rules for pharmaceutical data exclusivity protection. People's Republic of China's domestic law is consistent with the TRIPS agreement. In the drug registration approval process of the People's Republic of China's Drug Supervision Department, pharmaceutical data exclusivity protection has encountered some problems, including data authentication, exclusive rights to data, number of drugs requiring data to be submitted, and drug costs. In view of the long-term interests of the People's Republic of China's pharmaceutical industry and intellectual property protection trends, there are a lot of difficulties in the enforcement of pharmaceutical data exclusivity protection law that need to be overcome. Some measures can be taken, such as establishing a shorter data exclusivity protection period, only protecting the data submitted and relied on in the People's Republic of China, only protecting the drugs that use new chemical components, allowing application and necessary research before the expiry of pharmaceutical data exclusivity protection period of generic drugs. PMID:27382254

  5. The Seal of Approval.

    ERIC Educational Resources Information Center

    Ziv, Micaela

    1997-01-01

    Israel's Software Evaluation Project sets national standards for hardware and software that is used in schools. All courseware must be approved for technical requirements and pedagogical content. After approval, the courseware is certified for use within Israel's school system for 2 years. Three times each year, schools, inspectorates, and…

  6. 76 FR 43185 - Outer Continental Shelf Air Regulations Consistency Update for Virginia

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-20

    ... AGENCY 40 CFR Part 55 Outer Continental Shelf Air Regulations Consistency Update for Virginia AGENCY... approve an update to a portion of the Outer Continental Shelf (OCS) Air Regulations. Requirements applying...'' subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735,...

  7. 75 FR 51950 - Outer Continental Shelf Air Regulations Consistency Update for Massachusetts

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-24

    ... FR 63774), and the preamble to the final rule promulgated September 4, 1992 (57 FR 40792) for further... will be approved by EPA for inclusion in the SIP. On September 17, 2008 (73 FR 53718), EPA finalized a... final consistency update and to the preamble to the February 27, 2008 proposed consistency update (73...

  8. 14 CFR 417.17 - Launch reporting requirements and launch specific updates.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ..., including the launch vehicle, planned flight path, staging and impact locations, and any on-orbit activity... modification under § 417.11. (3) Thirty-day flight safety analysis update. A launch operator must file updated flight safety analysis products, using previously approved methodologies, for each launch no later...

  9. 14 CFR 417.17 - Launch reporting requirements and launch specific updates.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Notification. Not later than noon, EST, 15 days before each licensed flight, a launch operator must file a... modification under § 417.11. (3) Thirty-day flight safety analysis update. A launch operator must file updated flight safety analysis products, using previously approved methodologies, for each launch no later...

  10. Savannah River Site Approved Site Treatment Plan, 1998 Annual Update

    SciTech Connect

    Lawrence, B.

    1999-04-20

    The Compliance Plan Volume (Volume I) identifies project activity schedule milestones for achieving compliance with Land Disposal Restrictions. Information regarding the technical evaluation of treatment options for SRS mixed wastes is contained in the Background Volume (Volume II) and is provided for information.

  11. Savannah River Site approved site treatment plan, 2000 annual update

    SciTech Connect

    Lawrence, B.

    2000-04-20

    The Compliance Plan Volume (Volume 1) identifies project activity schedule milestones for achieving compliance with Land Disposal Restrictions. Information regarding the technical evaluation of treatment options for SRS mixed wastes is contained in the Background Volume (Volume 2) and is provided for information.

  12. 78 FR 66642 - Updating OSHA Standards Based on National Consensus Standards; Signage

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-06

    ...On June 13, 2013, OSHA published in the Federal Register (78 FR 35559) a direct final rule that revised its signage standards for general industry and construction by updating the references to national consensus standards approved by the American National Standards Institute, a clearinghouse that verifies that the criteria for approval of consensus standards have been met. OSHA stated in that......

  13. Emergency medical kit for commercial airlines: an update.

    PubMed

    Thibeault, Claude

    2002-06-01

    As expected, the issue of medical kits for commercial airlines continues to attract attention, especially in light of the recent United States regulation on the subject. As promised in its first recommendation in 1998, the Air Transport Medicine (ATM) Committee has continued to monitor medical kit usage as well as pharmaceutical scientific developments and wishes to propose an update to its 1998 recommendation. Lists of contents are provided for emergency medical kits of two types: 1) those without defibrillator/monitor or monitor; and 2) those with defibrillator/monitor or monitor alone. Follow up and updates on this issue will be an ongoing task of the ATM Committee. PMID:12056681

  14. Biosafe Nanoscale Pharmaceutical Adjuvant Materials

    PubMed Central

    Jin, Shubin; Li, Shengliang; Wang, Chongxi; Liu, Juan; Yang, Xiaolong; Wang, Paul C.; Zhang, Xin; Liang, Xing-Jie

    2014-01-01

    Thanks to developments in the field of nanotechnology over the past decades, more and more biosafe nanoscale materials have become available for use as pharmaceutical adjuvants in medical research. Nanomaterials possess unique properties which could be employed to develop drug carriers with longer circulation time, higher loading capacity, better stability in physiological conditions, controlled drug release, and targeted drug delivery. In this review article, we will review recent progress in the application of representative organic, inorganic and hybrid biosafe nanoscale materials in pharmaceutical research, especially focusing on nanomaterial-based novel drug delivery systems. In addition, we briefly discuss the advantages and notable functions that make these nanomaterials suitable for the design of new medicines; the biosafety of each material discussed in this article is also highlighted to provide a comprehensive understanding of their adjuvant attributes. PMID:25429253

  15. Volatile hydrocarbons in pharmaceutical solutions

    SciTech Connect

    Kroneld, R. )

    1991-07-01

    Volatile pollutants such as hydrocarbons have, during many years, been analysed in small concentrations in air, water, food, pharmaceutical solutions, and human blood and tissues. It has also been shown that such substances have unexpected consequences for cell cultures and scientific experiments. These substances also accumulate in patients receiving haemodialysis and these patients are exposed to quite high concentrations. The knowledge of the toxicity of such compounds has led to the development of maximum limit concentrations with the aim to decrease the exposure of humans. This paper discusses the problems of human exposure in general and especially through pharmaceutical solutions, and the possibilities of eliminating such compounds with the aim of decreasing the exposure as a hygienic challenge.

  16. Desperately seeking cancer drugs: explaining the emergence and outcomes of accelerated pharmaceutical regulation.

    PubMed

    Davis, Courtney; Abraham, John

    2011-07-01

    Government regulators have increasingly accelerated new cancer drugs on to the market by granting them approval based on less clinical data supporting drug efficacy than permitted under standard regulations. With more lenient regulatory standards, pharmaceutical companies have keenly sought to develop cancer drugs. Focusing on the US, this article examines how the emergence and implementation of such accelerated approvals should be understood, particularly in relation to corporate bias and disease-politics theories. Drawing on longitudinal and case study data analysis, it is argued that the emergence of accelerated approval regulations for cancer drugs should be regarded primarily as part of a deregulatory regime driven by the interests of the pharmaceutical industry in partnership with all major aspects of the state, rather than as a response to patient activism in the aftermath of AIDS. Furthermore, even in cases when some patients successfully demand accelerated marketing approval of cancer drugs, such approval by regulators, while in manufacturers' interests, may not be in the interests of patients' health because the political culture of the regulatory agency is reluctant to uphold its own techno-regulatory standards of public-health protection when that would challenge the agenda-setting influence of manufacturers, including industry collaborations with patients and the medical profession. PMID:21314687

  17. Updating Situation Models

    ERIC Educational Resources Information Center

    Zwaan, Rolf A.; Madden, Carol J.

    2004-01-01

    The authors examined how situation models are updated during text comprehension. If comprehenders keep track of the evolving situation, they should update their models such that the most current information, the here and now, is more available than outdated information. Contrary to this updating hypothesis, E. J. O'Brien, M. L. Rizzella, J. E.…

  18. Drugs Approved for Thyroid Cancer

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Thyroid Cancer This page lists cancer drugs approved by ... that are not listed here. Drugs Approved for Thyroid Cancer Cabozantinib-S-Malate Caprelsa (Vandetanib) Cometriq (Cabozantinib-S-Malate) ...

  19. Drugs Approved for Prostate Cancer

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Prostate Cancer This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Prostate Cancer Abiraterone Acetate Bicalutamide Cabazitaxel Casodex (Bicalutamide) Degarelix Docetaxel ...

  20. Drugs Approved for Brain Tumors

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Brain Tumors This page lists cancer drugs approved by ... that are not listed here. Drugs Approved for Brain Tumors Afinitor (Everolimus) Afinitor Disperz (Everolimus) Avastin (Bevacizumab) ...

  1. Drugs Approved for Breast Cancer

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Breast Cancer This page lists cancer drugs approved by the ... are not listed here. Drugs Approved to Prevent Breast Cancer Evista (Raloxifene Hydrochloride) Keoxifene (Raloxifene Hydrochloride) Nolvadex (Tamoxifen ...

  2. Drugs Approved for Bone Cancer

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Bone Cancer This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Bone Cancer Abitrexate (Methotrexate) Cosmegen (Dactinomycin) Dactinomycin Denosumab Doxorubicin Hydrochloride ...

  3. Drugs Approved for Myeloproliferative Disorders

    MedlinePlus

    ... Ask about Your Treatment Research Drugs Approved for Myeloproliferative Neoplasms This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Myeloproliferative Neoplasms Adriamycin PFS (Doxorubicin Hydrochloride) Adriamycin RDF (Doxorubicin Hydrochloride) ...

  4. Pharmaceutical cocrystals: walking the talk.

    PubMed

    Bolla, Geetha; Nangia, Ashwini

    2016-06-28

    Pharmaceutical cocrystals belong to a sub-class of cocrystals wherein one of the components is a drug molecule (or an active pharmaceutical ingredient, API) and the second is a benign food or drug grade additive (generally regarded as safe, GRAS). The two components are hydrogen-bonded in a fixed stoichiometric ratio in the crystal lattice. In the past decade, pharmaceutical cocrystals have demonstrated significant promise in their ability to modify the physicochemical and pharmacokinetic properties of drug substances, such as the solubility and dissolution rate, bioavailability, particle morphology and size, tableting and compaction, melting point, physical form, biochemical and hydration stability, and permeability. In this feature review, we highlight some prominent examples of drug cocrystals which exhibit variable hardness/softness and elasticity/plasticity depending on coformer selection, improvement of solubility and permeability in the same cocrystal, increase of the melting point for solid formulation, enhanced color performance, photostability and hydration stability, and a longer half-life. Cocrystals of flavanoids and polyphenols can make improved pharmaceuticals and also extend to the larger class of nutraceuticals. The application of crystal engineering to assemble ternary cocrystals expands this field to drug-drug cocrystals which may be useful in multi-drug resistance, mitigating side effects of drugs, or attenuating/enhancing drug action synergistically by rational selection. The advent of new techniques for structural characterization beyond the standard X-ray diffraction will provide a better understanding of drug phases which are at the borderline of crystalline-amorphous nature and even newer opportunities in the future. PMID:27278109

  5. Pharmaceutical development and regulatory considerations for nanoparticles and nanoparticulate drug delivery systems.

    PubMed

    Narang, Ajit S; Chang, Rong-Kun; Hussain, Munir A

    2013-11-01

    Pharmaceutical nanomaterials (NMs) encompass a wide variety of materials including drug nanoparticles (NPs), which can be amorphous or crystalline; or nanoparticulate drug delivery systems, such as micelles, microemulsions, liposomes, drug-polymer conjugates, and antibody-drug conjugates. These NMs are either transient or persistent-depending on whether the integrity of their structure and size is maintained until reaching the site of drug action. Examples of several approved drug products are included as pharmaceutical nanoparticulate systems along with a commentary on the current development issues and paradigms for various categories of NPs. This commentary discusses the preparation of nanoparticulate systems for commercial development, and the biopharmaceutical and pharmacokinetic advantages of these systems. A criterion of criticality is defined that incorporates the structure, in addition to size requirement of pharmaceutical NPs to identify systems that may require special development and regulatory considerations. PMID:24037829

  6. Pharmaceutical policies in Canada: another example of federal-provincial discord

    PubMed Central

    Anis, A H

    2000-01-01

    Pharmaceutical policy in Canada is set at both the federal and provincial levels of government. The federal government is responsible for intellectual property rights of manufacturers (patents) and the initial approval and labelling of prescription drugs and for ensuring overall market competitiveness. The provincial government has responsibility and jurisdiction over the funding of all health care services, including pharmaceuticals. Various interactions between the pharmaceutical industry, the federal and provincial governments and consumers have shaped the current landscape for prescription drugs in Canada. One key failing of the system is that the federal government is almost completely insulated from the impact of its policies because, although it regulates drug prices, it does not buy any drugs. In contrast, provincial governments have no jurisdiction over market competitiveness or pricing, yet end up paying for most of the drug expenditures incurred. PMID:10701389

  7. Nanotechnology and pharmaceutical inhalation aerosols.

    PubMed

    Patel, A R; Vavia, P R

    2007-02-01

    Pharmaceutical inhalation aerosols have been playing a crucial role in the health and well being of millions of people throughout the world for many years. The technology's continual advancement, the ease of use and the more desirable pulmonary-rather-than-needle delivery for systemic drugs has increased the attraction for the pharmaceutical aerosol in recent years. But administration of drugs by the pulmonary route is technically challenging because oral deposition can be high, and variations in inhalation technique can affect the quantity of drug delivered to the lungs. Recent advances in nanotechnology, particularly drug delivery field have encouraged formulation scientists to expand their reach in solving tricky problems related to drug delivery. Moreover, application of nanotechnology to aerosol science has opened up a new category of pharmaceutical aerosols (collectively known as nanoenabled-aerosols) with added advantages and effectiveness. In this review, some of the latest approaches of nano-enabled aerosol drug delivery system (including nano-suspension, trojan particles, bioadhesive nanoparticles and smart particle aerosols) that can be employed successfully to overcome problems of conventional aerosol systems have been introduced. PMID:17375556

  8. Stability of Pharmaceuticals in Space

    NASA Technical Reports Server (NTRS)

    Nguyen, Y-Uyen

    2009-01-01

    Stability testing is a tool used to access shelf life and effects of storage conditions for pharmaceutical formulations. Early research from the International Space Station (ISS) revealed that some medications may have degraded while in space. This potential loss of medication efficacy would be very dangerous to Crew health. The aim of this research project, Stability of Pharmacotherapeutic Compounds, is to study how the stability of pharmaceutical compounds is affected by environmental conditions in space. Four identical pharmaceutical payload kits containing medications in different dosage forms (liquid for injection, tablet, capsule, ointment and suppository) were transported to the ISS aboard a Space Shuttle. One of the four kits was stored on that Shuttle and the other three were stored on the ISS for return to Earth at various time intervals aboard a pre-designated Shuttle flight. The Pharmacotherapeutics laboratory used stability test as defined by the United States Pharmacopeia (USP), to access the degree of degradation to the Payload kit medications that may have occurred during space flight. Once these medications returned, the results of stability test performed on them were compared to those from the matching ground controls stored on Earth. Analyses of the results obtained from physical and chemical stability assessments on these payload medications will provide researchers additional tools to promote safe and efficacious medications for space exploration.

  9. Pharmaceutical study of Lauha Bhasma

    PubMed Central

    Singh, Neetu; Reddy, K. R. C.

    2010-01-01

    In the present research paper, the work done on pharmaceutical study of Lauha Bhasma conducted in the Department of Rasa Shastra under the postgraduate research programme is being presented. The pharmaceutical processing of Lauha Bhasma was performed by following samanya shodhana, vishesha shodhana and marana of Lauha. Under the process of marana, three specific pharmaceutical techniques were followed, viz. bhanupaka, sthalipaka and putapaka. During the putapaka process, an electric muffle furnace (EMF) was used. The temperature of puta was studied in two batches, viz. in Batch I, a temperature of 800°C was maintained whereas in Batch II, a temperature of 600°C was maintained. The purpose behind selecting two temperatures was to validate the process of marana of Lauha and to determine an ideal temperature for the preparation of Lauha Bhasma in EMF. It is found that after 20 puta at a temperature of 600°C, the Lauha Bhasma was prepared properly. The entire characteristic of Lauha Bhasma, like “pakwa jambu phala varna,” varitar, etc. was attained at 600°. At a temperature of 800°C, the process could not be carried out smoothly. The pellets turned very hard and brassy yellow in color. The desired color was attained only after decreasing the temperature in further puta. PMID:22131745

  10. [E-commerce of pharmaceuticals].

    PubMed

    Shani, Segev

    2003-05-01

    The emergence of the Internet as a new communications and information technology caused major social and cultural changes. The dramatic increase in accessibility and availability of information empowered the consumer by closing the information gap between the consumer and different suppliers. The objective of this article is to review many new internet-supported applications related to the pharmaceutical market. E-commerce is divided into two major components: Business to Consumer (B to C), and Business to Business (B to B). The main applications in B to C are dissemination of medical and drug information, and the sale of drugs through the Internet. Medical information on the Internet is vast and very helpful for patients, however, its reliability is not guaranteed. Online pharmacies increase the accessibility and availability of drugs. Nevertheless, several obstacles such as security of the data provided (both financial and clinical) prevent the widespread use of online pharmacies. Another risk is the health authorities' inability to regulate Internet sites effectively. Therefore, unregulated sale of prescription drugs, fake or substandard, often occurs on the Internet. B to B relates to physicians, clinics, hospitals, HMO's and pharmaceutical companies. There is a vast number of applications ranging from clinical research, marketing and sales promotion, to drug distribution and logistics. In conclusion, the Internet is dynamic and has contributed to the development of numerous new applications in the field of pharmaceuticals. Regulatory authorities should be active in developing new policies that will deal with those new Internet-based applications. PMID:12803063

  11. Pharmaceutical study of Lauha Bhasma.

    PubMed

    Singh, Neetu; Reddy, K R C

    2010-07-01

    In the present research paper, the work done on pharmaceutical study of Lauha Bhasma conducted in the Department of Rasa Shastra under the postgraduate research programme is being presented. The pharmaceutical processing of Lauha Bhasma was performed by following samanya shodhana, vishesha shodhana and marana of Lauha. Under the process of marana, three specific pharmaceutical techniques were followed, viz. bhanupaka, sthalipaka and putapaka. During the putapaka process, an electric muffle furnace (EMF) was used. The temperature of puta was studied in two batches, viz. in Batch I, a temperature of 800°C was maintained whereas in Batch II, a temperature of 600°C was maintained. The purpose behind selecting two temperatures was to validate the process of marana of Lauha and to determine an ideal temperature for the preparation of Lauha Bhasma in EMF. It is found that after 20 puta at a temperature of 600°C, the Lauha Bhasma was prepared properly. The entire characteristic of Lauha Bhasma, like "pakwa jambu phala varna," varitar, etc. was attained at 600°. At a temperature of 800°C, the process could not be carried out smoothly. The pellets turned very hard and brassy yellow in color. The desired color was attained only after decreasing the temperature in further puta. PMID:22131745

  12. Examining pharmaceuticals using terahertz spectroscopy

    NASA Astrophysics Data System (ADS)

    Sulovská, Kateřina; Křesálek, Vojtěch

    2015-10-01

    Pharmaceutical trafficking is common issue in countries where they are under stricter dispensing regime with monitoring of users. Most commonly smuggled pharmaceuticals include trade names Paralen Plus, Modafen, Clarinase repetabs, Aspirin complex, etc. These are transported mainly from Eastern Europe (e.g. Poland, Ukraine, Russia) to countries like Czech Republic, which is said to have one of the highest number of methamphetamine producers in Europe. The aim of this paper is to describe the possibility of terahertz spectroscopy utilization as an examining tool to distinguish between pharmaceuticals containing pseudoephedrine compounds and those without it. Selected medicaments for experimental part contain as an active ingredient pseudoephedrine hydrochloride or pseudoephedrine sulphate. Results show a possibility to find a pseudoephedrine compound spectra in samples according to previously computed and experimentally found ones, and point out that spectra of same brand names pills may vary according to their expiration date, batch, and amount of absorbed water vapours from ambience. Mislead spectrum also occurs during experimental work in a sample without chosen active ingredient, which shows persistent minor inconveniences of terahertz spectroscopy. All measurement were done on the TPS Spectra 3000 instrument.

  13. 77 FR 62431 - Adoption of Updated EDGAR Filer Manual

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-15

    ... COMMISSION 17 CFR Part 232 Adoption of Updated EDGAR Filer Manual AGENCY: Securities and Exchange Commission... revisions to the Electronic Data Gathering, Analysis, and Retrieval System (EDGAR) Filer Manual and related... Manual is approved by the Director of the Federal Register as of October 15, 2012. FOR...

  14. 78 FR 29616 - Adoption of Updated EDGAR Filer Manual

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-21

    ... COMMISSION 17 CFR Part 232 Adoption of Updated EDGAR Filer Manual AGENCY: Securities and Exchange Commission... revisions to the Electronic Data Gathering, Analysis, and Retrieval System (EDGAR) Filer Manual and related... incorporation by reference of the EDGAR Filer Manual is approved by the Director of the Federal Register as...

  15. 78 FR 60684 - Adoption of Updated EDGAR Filer Manual

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-02

    ... COMMISSION 17 CFR Part 232 Adoption of Updated EDGAR Filer Manual AGENCY: Securities and Exchange Commission... revisions to the Electronic Data Gathering, Analysis, and Retrieval System (EDGAR) Filer Manual and related... incorporation by reference of the EDGAR Filer Manual is approved by the Director of the Federal Register as...

  16. Duchenne muscular dystrophy drugs face tough path to approval.

    PubMed

    Hodgkinson, L; Sorbera, L; Graul, A I

    2016-03-01

    Highly anticipated as new disease-modifying treatments for Duchenne muscular dystrophy (DMD), therapeutics by BioMarin Pharmaceutical (Kyndrisa™; drisapersen) and Sarepta Therapeutics (eteplirsen; AVI-4658) both recently received negative FDA reviews and are now facing battles for approval in the U.S. At present, BioMarin is committed to working with the FDA to forge a pathway to approval following the failure of its NDA, while Sarepta awaits the formal decision on its NDA, which is expected by late May 2016. Despite the critical nature of both reviews, analysts consider that there is still a narrow possibility of approval of both drugs. According to Consensus forecasts from Thomson Reuters Cortellis for Competitive Intelligence, Kyndrisa is forecast to achieve sales of USD 533.71 million in 2021. PMID:27186594

  17. Sofosbuvir: first global approval.

    PubMed

    Keating, Gillian M; Vaidya, Asha

    2014-02-01

    Sofosbuvir (Solvadi™), a nucleotide analogue hepatitis C virus NS5B polymerase inhibitor, is under development with Gilead Sciences for the once-daily, oral treatment of chronic hepatitis C. Oral sofosbuvir has been approved in the US for the treatment of chronic hepatitis C as a component of a combination antiviral regimen. In addition, the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the approval of sofosbuvir for the treatment of chronic hepatitis C. This article summarizes the milestones in the development of sofosbuvir leading to this first approval for chronic hepatitis C. PMID:24442794

  18. RNAi as a tool for target discovery in early pharmaceutical research.

    PubMed

    Adams, R; Steckel, M; Nicke, B; Pohlenz, H D

    2016-01-01

    The pharmaceutical industry is currently faced with increasing pressure due to patent expirations for block busters, healthcare reforms with strained budgets and growing demands for approval by administrative organizations like the FDA and the EMA. High attrition rates especially in the later expensive stages of the drug development process ask for thoroughly validated drug targets at the beginning of such projects. The great potential of RNA interference strategies toward reaching this goal is outlined in this article. PMID:26867351

  19. Completeness assessment of type II active pharmaceutical ingredient drug master files under generic drug user fee amendment: review metrics and common incomplete items.

    PubMed

    Zhang, Huyi; Li, Haitao; Song, Wei; Shen, Diandian; Skanchy, David; Shen, Kun; Lionberger, Robert A; Rosencrance, Susan M; Yu, Lawrence X

    2014-09-01

    Under the Generic Drug User Fee Amendments (GDUFA) of 2012, Type II active pharmaceutical ingredient (API) drug master files (DMFs) must pay a user fee and pass a Completeness Assessment (CA) before they can be referenced in an Abbreviated New Drug Application (ANDA), ANDA amendment, or ANDA prior approval supplement (PAS). During the first year of GDUFA implementation, from October 1, 2012 to September 30, 2013, approximately 1,500 Type II API DMFs received at least one cycle of CA review and more than 1,100 Type II DMFs were deemed complete and published on FDA's "Available for Reference List". The data from CA reviews were analyzed for factors that influenced the CA review process and metrics, as well as the areas of DMF submissions which most frequently led to an incomplete CA status. The metrics analysis revealed that electronic DMFs appear to improve the completeness of submission and shorten both the review and response times. Utilizing the CA checklist to compile and proactively update the DMFs improves the chance for the DMFs to pass the CA in the first cycle. However, given that the majority of DMFs require at least two cycles of CA before being deemed complete, it is recommended that DMF fees are paid 6 months in advance of the ANDA submissions in order to avoid negatively impacting the filling status of the ANDAs. PMID:25034968

  20. In Silico Models for Ecotoxicity of Pharmaceuticals.

    PubMed

    Roy, Kunal; Kar, Supratik

    2016-01-01

    Pharmaceuticals and their active metabolites are one of the significantly emerging environmental toxicants. The major routes of entry of pharmaceuticals into the environment are industries, hospitals, or direct disposal of unwanted or expired drugs made by the patient. The most important and distinct features of pharmaceuticals are that they are deliberately designed to have an explicit mode of action and designed to exert an effect on humans and other living systems. This distinctive feature makes pharmaceuticals and their metabolites different from other chemicals, and this necessitates the evaluation of the direct effects of pharmaceuticals in various environmental compartments as well as to living systems. In this background, the alarming situation of ecotoxicity of diverse pharmaceuticals have forced government and nongovernment regulatory authorities to recommend the application of in silico methods to provide quick information about the risk assessment and fate properties of pharmaceuticals as well as their ecological and indirect human health effects. This chapter aims to offer information regarding occurrence of pharmaceuticals in the environment, their persistence, environmental fate, and toxicity as well as application of in silico methods to provide information about the basic risk management and fate prediction of pharmaceuticals in the environment. Brief ideas about toxicity endpoints, available ecotoxicity databases, and expert systems employed for rapid toxicity predictions of ecotoxicity of pharmaceuticals are also discussed. PMID:27311470

  1. 42 CFR 495.340 - As-needed HIT PAPD update and as-needed HIT IAPD update requirements.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... update or a HIT IAPD no later than 60 days after the occurrence of project changes including but not... document or the HIT implementation advance planning document. (d) A change in implementation concept or a change to the scope of the project. (e) A change to the approved cost allocation methodology....

  2. Student Evaluation of Online Pharmaceutical Compounding Videos

    PubMed Central

    Park, Hanna L.

    2016-01-01

    Objective. To describe pharmacy students’ views on the effectiveness of an expansion of the compounding laboratory website at the UNC Eshelman School of Pharmacy. Methods. Originally, there were 39 videos and three animations available. In 2011, an additional 59 videos and two animations were added. Concurrently, all of the interactive questions were updated to fully integrate with the expanded video library. Students were surveyed about the expanded video library regarding accessibility, functionality, and usefulness, and how using the library impacted their learning of compounding. Surveys were analyzed with descriptive statistics. Means and SDs were calculated for the rating scale questions; independent t tests and Wilcoxon nonparametric tests were used to find differences between professional classes and campuses. Analytical results were evaluated with a one-way analysis of variance (ANOVA), z test, and a homogeneity of variance (Levene’s) test. Results. The response rate to the survey was 85%. Compounding videos were used by 386/391 students. Thirty-four percent of students used the videos an average of 30 minutes or less per week; 56% used the videos 1–2 hours per week. Approximately 80% of students were satisfied with the functionality and accessibility of the videos. All students, regardless of professional year or campus affiliation, put their confidence/competence at about 70% of the rating scale. Conclusions. As no standardized compounding curriculum was found in US schools of pharmacy and students reported being satisfied with the website, it could be an accessible, functional, and useful resource for pharmaceutical compounding in schools of pharmacy. PMID:27073283

  3. Student Evaluation of Online Pharmaceutical Compounding Videos.

    PubMed

    Park, Hanna L; Shrewsbury, Robert P

    2016-03-25

    Objective. To describe pharmacy students' views on the effectiveness of an expansion of the compounding laboratory website at the UNC Eshelman School of Pharmacy. Methods. Originally, there were 39 videos and three animations available. In 2011, an additional 59 videos and two animations were added. Concurrently, all of the interactive questions were updated to fully integrate with the expanded video library. Students were surveyed about the expanded video library regarding accessibility, functionality, and usefulness, and how using the library impacted their learning of compounding. Surveys were analyzed with descriptive statistics. Means and SDs were calculated for the rating scale questions; independent t tests and Wilcoxon nonparametric tests were used to find differences between professional classes and campuses. Analytical results were evaluated with a one-way analysis of variance (ANOVA), z test, and a homogeneity of variance (Levene's) test. Results. The response rate to the survey was 85%. Compounding videos were used by 386/391 students. Thirty-four percent of students used the videos an average of 30 minutes or less per week; 56% used the videos 1-2 hours per week. Approximately 80% of students were satisfied with the functionality and accessibility of the videos. All students, regardless of professional year or campus affiliation, put their confidence/competence at about 70% of the rating scale. Conclusions. As no standardized compounding curriculum was found in US schools of pharmacy and students reported being satisfied with the website, it could be an accessible, functional, and useful resource for pharmaceutical compounding in schools of pharmacy. PMID:27073283

  4. Issues in pharmaceutical development of thymosin alpha1 from preclinical studies through marketing.

    PubMed

    Tuthill, Cynthia

    2007-09-01

    SciClone Pharmaceuticals licensed the commercial and patent rights to thymosin alpha1, for geographical regions of the world excluding the United States and Europe, in the early 1990s. With this license, SciClone embarked on global drug development, and the issues encountered for thymosin alpha1 are reflective of the roller coaster of modern approval of pharmaceuticals. Most of the required toxicology studies had been completed prior to licensure, but some newer studies had to be conducted to obtain approvals in certain countries. The recent development of the "International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use" (ICH) guidelines allows for a clearer definition of the required battery of toxicology studies, although some countries still have not adopted these guidelines, and the local regulations have had to be understood and followed. Other hurdles include the complications that manufacturing requirements can differ between countries, and certain countries require local clinical experience trials in addition to SciClone's cumulative clinical data. A further obstacle was the pleiotropic nature of the mechanism of action of thymosin alpha1, with the resulting difficulty in the unraveling of its pharmacologic effects. With close attention to these regulatory details, SciClone has obtained approvals in more than 30 countries and has successfully begun commercial sales. PMID:17947591

  5. Drugs Approved for Melanoma

    MedlinePlus

    ... are not listed here. Drugs Approved for Melanoma Aldesleukin Cobimetinib Cotellic (Cobimetinib) Dabrafenib Dacarbazine DTIC-Dome (Dacarbazine) IL-2 (Aldesleukin) Imlygic (Talimogene Laherparepvec) Interleukin-2 (Aldesleukin) Intron A ( ...

  6. Drugs Approved for Leukemia

    Cancer.gov

    This page lists cancer drugs approved by the FDA for use in leukemia. The drug names link to NCI's Cancer Drug Information summaries. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  7. Drugs Approved for Retinoblastoma

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for retinoblastoma. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  8. Drugs Approved for Neuroblastoma

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for neuroblastoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  9. Medicines information provided by pharmaceutical representatives: a comparative study in Australia and Malaysia

    PubMed Central

    2010-01-01

    Background Pharmaceutical representatives provide medicines information on their promoted products to doctors. However, studies have shown that the quality of this information is often low. No study has assessed the medicines information provided by pharmaceutical representatives to doctors in Malaysia and no recent evidence in Australia is present. We aimed to compare the provision of medicines information by pharmaceutical representatives to doctors in Australia and Malaysia. Methods Following a pharmaceutical representative's visit, general practitioners in Australia and Malaysia who had agreed to participate, were asked to fill out a questionnaire on the main product and claims discussed during the encounter. The questionnaire focused on provision of product information including indications, adverse effects, precautions, contraindications and the provision of information on the Pharmaceutical Benefit Scheme (PBS) listings and restrictions (in Australia only). Descriptive statistics were produced. Chi-square analysis and clustered linear regression were used to assess differences in Australia and Malaysia. Results Significantly more approved product information sheets were provided in Malaysia (78%) than in Australia (53%) (P < 0.001). In both countries, general practitioners reported that indications (Australia, 90%, Malaysia, 93%) and dosages (Australia, 76%, Malaysia, 82%) were frequently provided by pharmaceutical representatives. Contraindications, precautions, drug interactions and adverse effects were often omitted in the presentations (range 25% - 41%). General practitioners in Australia and Malaysia indicated that in more than 90% of presentations, pharmaceutical representatives partly or fully answered their questions on contraindications, precautions, drug interactions and adverse effects. More general practitioners in Malaysia (85%) than in Australia (60%) reported that pharmaceutical representatives should have mentioned contraindications

  10. Pharmacodynamics of Memantine: An Update

    PubMed Central

    Rammes, G; Danysz, W; Parsons, C.G

    2008-01-01

    Memantine received marketing authorization from the European Agency for the Evaluation of Medicinal Products (EMEA) for the treatment of moderately severe to severe Alzheimer´s disease (AD) in Europe on 17th May 2002 and shortly thereafter was also approved by the FDA for use in the same indication in the USA. Memantine is a moderate affinity, uncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist with strong voltage-dependency and fast kinetics. Due to this mechanism of action (MOA), there is a wealth of other possible therapeutic indications for memantine and numerous preclinical data in animal models support this assumption. This review is intended to provide an update on preclinical studies on the pharmacodynamics of memantine, with an additional focus on animal models of diseases aside from the approved indication. For most studies prior to 1999, the reader is referred to a previous review [196]. In general, since 1999, considerable additional preclinical evidence has accumulated supporting the use of memantine in AD (both symptomatic and neuroprotective). In addition, there has been further confirmation of the MOA of memantine as an uncompetitive NMDA receptor antagonist and essentially no data contradicting our understanding of the benign side effect profile of memantine. PMID:19305788

  11. Introduction: Institutional corruption and the pharmaceutical policy.

    PubMed

    Rodwin, Marc A

    2013-01-01

    Today, the goals of pharmaceutical policy and medical practice are often undermined due to institutional corruption - that is, widespread or systemic practices, usually legal, that undermine an institution's objectives or integrity. In this symposium, 16 articles investigate the corruption of pharmaceutical policy, each taking a different look at the sources of corruption, how it occurs, and what is corrupted. We will see that the pharmaceutical industry's own purposes are often undermined. Furthermore, pharmaceutical industry funding of election campaigns and lobbying skews the legislative process that sets pharmaceutical policy. Moreover, certain practices have corrupted medical research, the production of medical knowledge, the practice of medicine, drug safety, the Food and Drug Administration's oversight of the pharmaceutical market, and the trustworthiness of patient advocacy organizations. PMID:24088143

  12. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Forty-ninth report.

    PubMed

    2015-01-01

    The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use. Revised procedure for the development of monographs and other texts for The International Pharmacopoeia; Revised updating mechanism for the section on radiopharmaceuticals in The International Pharmacopoeia; Revision of the supplementary guidelines on good manufacturing practices: validation, Appendix 7: non-sterile process validation; General guidance for inspectors on hold-time studies; 16 technical supplements to Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products; Recommendations for quality requirements when plant-derived artemisinin is used as a starting material in the production of antimalarial active pharmaceutical ingredients; Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability: revision; Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products: revision; and Good review practices: guidelines for national and regional regulatory authorities. PMID:26118121

  13. Evaluation of P-Listed Pharmaceutical Residues in Empty Pharmaceutical Containers

    EPA Science Inventory

    Under the Resource Conservation and Recovery Act (RCRA), some pharmaceuticals are considered acute hazardous wastes because their sole active pharmaceutical ingredients are P-listed commercial chemical products (40 CFR 261.33). Hospitals and other healthcare facilities have stru...

  14. New strategies for pharmaceutical design.

    PubMed

    Gillmor, S A; Cohen, F E

    1993-01-01

    Parallel synthesis and testing procedures are being investigated to shorten the drug design and discovery process. These procedures have focused on peptides and nucleotides, although these compounds are unlikely to be useful therapeutics because of their low bioavailability and sensitivity to enzymatic degradation. More recently, the use of other modular systems with distinct linking chemistries have been explored. Structural data combined with computational screens of compound databases provides an alternative method to identify novel nonpeptide pharmaceuticals. When structural information is not available, homology-based models have proved to be sufficient to identify nonpeptide inhibitors active at low micromolar concentrations against important enzymes in parasite life cycles. PMID:8167566

  15. Punishments: What Predicts Adult Approval.

    ERIC Educational Resources Information Center

    Buntain-Ricklefs, Joanne J.; And Others

    1994-01-01

    A survey of 449 parents found that 24% experienced uncommon punishments (such as burning) during their childhoods and 6% approved; 45% experienced and 17% approved of common punishments (shaking); and 94% experienced and 88% approved of very common punishments (spanking). Approval of each punishment was related to experience. Race, income, and…

  16. Entrepreneurial patent management in pharmaceutical startups.

    PubMed

    Holgersson, Marcus; Phan, Tai; Hedner, Thomas

    2016-07-01

    Startups fill an increasingly important role as innovators in the pharmaceutical industry, and patenting is typically central to their success. This article aims to explore patent management in pharmaceutical startups. The results show that startups need to deal with several challenges related to patenting and an 'entrepreneurial' approach to patent management is called for. Resource constraints, venture capital provision, exits and other conditions and events must be readily considered in the patent management process to build a successful pharmaceutical venture, something that could benefit the pharmaceutical industry as a whole. PMID:26948802

  17. Specialty pharmaceuticals: developing a management plan.

    PubMed

    Willcutts, Dave

    2002-01-01

    This is the first in a series of articles that address the complex issues associated with specialty pharmaceuticals in the development of a successful specialty pharmaceutical program, a critical component of managing this high-cost and highly fragmented sector. This article focuses on how to define specialty pharmaceuticals. Other articles in this series will explore such topics as the mechanics of developing and managing a specialty pharmaceutical program, how and when to establish clinical protocols and authorizations, the importance of data management, and the benefits from automated processes. PMID:12561391

  18. Moving Objects Updating

    NASA Astrophysics Data System (ADS)

    Chen, Jidong; Meng, Xiaofeng

    In moving objects applications, large numbers of locations can be sampled by sensors or GPS periodically, then sent from moving clients to the server and stored in a database. Therefore, continuously maintaining in a database the current locations of moving objects by using a tracking technique becomes very important. The key issue is minimizing the number of updates, while providing precise locations for query results. In this chapter, we will introduce some underlying location update methods. Then, we describe two location update strategies in detail, which can improve the performance. One is the proactive location update strategy, which predicts the movement of moving objects to lower the update frequency; the other is the group location update strategy, which groups the objects to minimize the total number of objects reporting their locations.

  19. Ibrutinib: first global approval.

    PubMed

    Cameron, Fiona; Sanford, Mark

    2014-02-01

    Ibrutinib (Imbruvica™) is a small molecule, first-in-class, once-daily, orally available, Bruton's tyrosine kinase inhibitor that is under development for the treatment of B cell malignancies, including chronic lymphocytic leukaemia (CLL), mantle cell lymphoma (MCL) and diffuse large B cell lymphoma (DLBCL), as well as multiple myeloma (MM), follicular lymphoma (FL) and Waldenstrom's macroglobulinemia (WM). It has been developed by Pharmacyclics, Inc. and Janssen Biotech, Inc. Ibrutinib acts by blocking B-cell antigen receptor signalling, thereby reducing malignant proliferation of B cells and inducing cell death. Based chiefly on findings from a phase Ib/II study, ibrutinib has been approved in the USA for the treatment of MCL in previously treated patients and is one of the first approvals through the US FDA's Breakthrough Therapy Designation Pathway. An application has been filed in the EU seeking regulatory approval in this indication. In both the USA and EU, further applications have been filed with regulatory bodies seeking approval for the use of ibrutinib in patients with previously treated CLL/small lymphocytic lymphoma (SLL). Phase III trials are underway worldwide to evaluate ibrutinib in the treatment of patients with CLL/SLL, DLBCL and MCL, and the agent is in phase II development for use in WM, FL and MM. This article summarizes the milestones in the development of ibrutinib leading to its first approval in MCL. PMID:24464309

  20. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.99 Notice of approval or... approval or disapproval of the machine. (a) If the qualified electrical representative recommends...

  1. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ..., DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.99 Notice of approval or... approval or disapproval of the machine. (a) If the qualified electrical representative recommends...

  2. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ..., DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.99 Notice of approval or... approval or disapproval of the machine. (a) If the qualified electrical representative recommends...

  3. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ..., DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.99 Notice of approval or... approval or disapproval of the machine. (a) If the qualified electrical representative recommends...

  4. 30 CFR 18.99 - Notice of approval or disapproval; letters of approval and approval plates.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ..., DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS ELECTRIC MOTOR-DRIVEN MINE EQUIPMENT AND ACCESSORIES Field Approval of Electrically Operated Mining Equipment § 18.99 Notice of approval or... approval or disapproval of the machine. (a) If the qualified electrical representative recommends...

  5. ISS Update: Suitport

    NASA Video Gallery

    ISS Update commentator Lynnette Madison interviews Mallory Jennings, Suitport Human Testing Lead, about making spacewalks easier and more efficient with the Suitport. Questions? Ask us on Twitter @...

  6. The productivity crisis in pharmaceutical R&D.

    PubMed

    Pammolli, Fabio; Magazzini, Laura; Riccaboni, Massimo

    2011-06-01

    Advances in the understanding of the molecular basis of diseases have expanded the number of plausible therapeutic targets for the development of innovative agents in recent decades. However, although investment in pharmaceutical research and development (R&D) has increased substantially in this time, the lack of a corresponding increase in the output in terms of new drugs being approved indicates that therapeutic innovation has become more challenging. Here, using a large database that contains information on R&D projects for more than 28,000 compounds investigated since 1990, we examine the decline of R&D productivity in pharmaceuticals in the past two decades and its determinants. We show that this decline is associated with an increasing concentration of R&D investments in areas in which the risk of failure is high, which correspond to unmet therapeutic needs and unexploited biological mechanisms. We also investigate the potential variations in productivity with regard to the regional location of companies and find that although companies based in the United States and Europe differ in the composition of their R&D portfolios, there is no evidence of any productivity gap. PMID:21629293

  7. Optimizing the yield of recombinant pharmaceutical proteins in plants.

    PubMed

    Twyman, Richard M; Schillberg, Stefan; Fischer, Rainer

    2013-01-01

    The production of recombinant pharmaceutical proteins in plants is entering a new phase with the recent approval of recombinant glucocerebrosidase produced in carrot cells and the successful production of clinical-grade proteins in diverse plant-based production platforms. In the long journey from concept to product, the field of molecular farming has faced technical and economic hurdles, many reflecting the initially limited productivity of plants compared to established platforms such as mammalian cells. This challenge has been met by innovative research aiming to increase recombinant protein yields and maximize the economic benefits of plants. Research has focused on increasing the intrinsic yield capability of plants by optimizing expression construct design, and also on novel strategies to avoid epigenetic silencing and environmental effects on protein accumulation. In this article, we discuss the diverse approaches that have been used to increase the productivity of plant-based platforms for the production of recombinant pharmaceutical proteins and consider future opportunities to maximize the potential of plants and increase their competitiveness outside niche markets. PMID:23394567

  8. Gene-targeting pharmaceuticals for single-gene disorders.

    PubMed

    Beaudet, Arthur L; Meng, Linyan

    2016-04-15

    The concept of orphan drugs for treatment of orphan genetic diseases is perceived enthusiastically at present, and this is leading to research investment on the part of governments, disease-specific foundations and industry. This review attempts to survey the potential to use traditional pharmaceuticals as opposed to biopharmaceuticals to treat single-gene disorders. The available strategies include the use of antisense oligonucleotides (ASOs) to alter splicing or knock-down expression of a transcript, siRNAs to knock-down gene expression and drugs for nonsense mutation read-through. There is an approved drug for biallelic knock-down of the APOB gene as treatment for familial hypercholesterolemia. Both ASOs and siRNAs are being explored to knock-down the transthyretin gene to prevent the related form of amyloidosis. The use of ASOs to alter gene-splicing to treat spinal muscular atrophy is in phase 3 clinical trials. Work is progressing on the use of ASOs to activate the normally silent paternal copy of the imprinted UBE3A gene in neurons as a treatment for Angelman syndrome. A gene-activation or gene-specific ramp-up strategy would be generally helpful if such could be developed. There is exciting theoretical potential for converting biopharmaceutical strategies such gene correction and CRISPR-Cas9 editing to a synthetic pharmaceutical approach. PMID:26628634

  9. MSHA approval process

    SciTech Connect

    Chirdon, D.C.

    1999-07-01

    The hazardous nature of the underground mining environment necessitates the use of equipment and mining products designed to ensure safe usage in this hostile environment. Title 30, code of federal regulations (30 CFR) includes requirements that all equipment and products intended for use in potentially gassy areas of underground mines be approved by the mine safety and health administration (MSHA). Design and performance requirements for many of the products intended for use in the underground environment are also part of 30 CFR. This paper describes the processes available to potential applicants for obtaining MSHA approval. Emphasis is placed on ventilation-related products. A program available to operators for modifying approved equipment is described. A proposed regulation that would broaden the scope of design standards accepted by MSHA is discussed.

  10. Ramucirumab: first global approval.

    PubMed

    Poole, Raewyn M; Vaidya, Asha

    2014-06-01

    Ramucirumab (Cyramza™ [US]), a fully human immunoglobulin G1 (IgG1) monoclonal antibody that inhibits vascular endothelial growth factor receptor-2 (VEGFR-2), has been developed by Eli Lilly (formerly ImClone Systems) for the treatment of cancer. Ramucirumab has received its first global approval in the US for use as monotherapy in the treatment of advanced or metastatic gastric cancer or gastro-oesophageal junction adenocarcinoma in patients who experience disease progression on or after fluoropyrimidine- or platinum-containing chemotherapy. Ramucirumab is the first treatment to be approved by the US FDA for this setting. This article summarizes the milestones in the development of ramucirumab leading to this first approval for the treatment of gastric cancer and gastro-oesophageal junction adenocarcinoma. PMID:24916147

  11. Marketing approval of mogamulizumab

    PubMed Central

    Beck, Alain; Reichert, Janice M.

    2012-01-01

    Therapeutic properties of antibodies strongly depend on the composition of their glycans. Most of the currently approved antibodies are produced in mammalian cell lines, which yield mixtures of different glycoforms that are close to those of humans, but not fully identical. Glyco-engineering is being developed as a method to control the composition of carbohydrates and to enhance the pharmacological properties of mAbs. The recent approval in Japan of mogamulizumab (POTELIGEO®), the first glyco-engineered antibody to reach the market, is a landmark in the field of therapeutic antibodies. Mogamulizumab is a humanized mAb derived from Kyowa Hakko Kirin’s POTELLIGENT® technology, which produces antibodies with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) activity. The approval was granted April 30, 2012 by the Japanese Ministry of Health, Labour and Welfare for patients with relapsed or refractory CCR4-positive adult T-cell leukemia-lymphoma. PMID:22699226

  12. Synthetic biology advances for pharmaceutical production

    PubMed Central

    Breitling, Rainer; Takano, Eriko

    2015-01-01

    Synthetic biology enables a new generation of microbial engineering for the biotechnological production of pharmaceuticals and other high-value chemicals. This review presents an overview of recent advances in the field, describing new computational and experimental tools for the discovery, optimization and production of bioactive molecules, and outlining progress towards the application of these tools to pharmaceutical production systems. PMID:25744872

  13. The Impact of Biotechnology on Pharmaceutics.

    ERIC Educational Resources Information Center

    Block, Lawrence H.

    1990-01-01

    The emergence of bioactive peptides and proteins as new drug species poses formidable problems for the pharmaceutical scientist. Implications for revision or change in undergraduate and graduate pharmaceutics curricula derive from the biopharmaceutical, pharmacokinetic, and physiochemical aspects of the new drug species, which differ from…

  14. Pharmaceutical experiment aboard STS-67 mission

    NASA Technical Reports Server (NTRS)

    1995-01-01

    Astronaut William G. Gregory, pilot, works with a pharmaceutical experiment on the middeck of the Earth-orbiting Space Shuttle Endeavour during the STS-67 mission. Commercial Materials Dispersion Apparatus Instruments Technology Associates Experiments (CMIX-03) includes not only pharmaceutical, but also biotechnology, cell biology, fluids, and crystal growth investigation

  15. Biotech pharmaceuticals and biotherapy: an overview.

    PubMed

    Steinberg, F M; Raso, J

    1998-01-01

    Broadly, the history of pharmaceutical biotechnology includes Alexander Fleming"s discovery of penicillin in a common mold, in 1928, and the subsequent development-prompted by World War II injuries-of large-scale manufacturing methods to grow the organism in tanks of broth. Pharmaceutical biotechnology has since changed enormously. Two breakthroughs of the late 1970s became the basis of the modern biotech industry: the interspecies transplantation of genetic material, and the fusion of tumor cells and certain leukocytes. The cells resulting from such fusion-hybridomas-replicate endlessly and can be geared to produce specific antibodies in bulk. Modern pharmaceutical biotechnology encompasses gene cloning and recombinant DNA technology. Gene cloning comprises isolating a DNA-molecule segment that corresponds to a single gene and synthesizing ("copying") the segment. Recombinant DNA technology, or gene splicing, comprises altering genetic material outside an organism-for example, by inserting into a DNA molecule a segment from a very different DNA molecule-and making the altered material (recombinant DNA) function in living things. Recombinant DNA technology enables modifying microorganisms, animals, and plants so that they yield medically useful substances, particularly scarce human proteins (by giving animals human genes, for example). This review, however, focuses not on pharmaceutical biotechnology"s methods but on its products, notably recombinant pharmaceuticals. It describes various types of biotech pharmaceuticals, their safety and effectiveness relative to the safety and effectiveness of conventionally produced pharmaceuticals, and the regulation of biotech pharmaceuticals. PMID:10945918

  16. Brivaracetam: First Global Approval.

    PubMed

    Markham, Anthony

    2016-03-01

    Brivaracetam (Briviact(®)), a 4-n-propyl analogue of levetiracetam developed by UCB Pharma, has been approved in the EU as an adjunctive therapy for the treatment of partial-onset seizures. Brivaracetam binds to synaptic vesicle glycoprotein 2a (SV2A) in the brain with greater selectivity and 15- to 30-fold higher affinity than levetiracetam, as demonstrated in preclinical models, and has demonstrated efficacy in reducing the frequency of partial onset seizures in clinical trials. This article summarizes the milestones in the development of brivaracetam leading to this first approval for use as adjunctive therapy for uncontrolled partial-onset seizures in adults with epilepsy. PMID:26899665

  17. Migalastat: First Global Approval.

    PubMed

    Markham, Anthony

    2016-07-01

    Migalastat (Galafold™)-a small molecule drug developed by Amicus Therapeutics that restores the activity of specific mutant forms of α-galactosidase-has been approved for the treatment of Fabry disease in the EU in patients with amenable mutations. Fabry disease is a rare disorder that results in a deficiency or absence of α-galactosidase, leading to accumulation of globotriaosylceramide in the lysosomes of various cells. This article summarizes the milestones in the development of migalastat leading to this first approval in the EU for the long-term treatment of adults and adolescents aged ≥16 years with a confirmed diagnosis of Fabry disease. PMID:27351440

  18. Brodalumab: First Global Approval.

    PubMed

    Greig, Sarah L

    2016-09-01

    Brodalumab (Lumicef(®)) is a human monoclonal immunoglobulin G antibody that is being developed by Kyowa Hakko Kirin in Japan, where it has been approved for the treatment of psoriasis vulgaris, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma. Brodalumab binds with high affinity to interleukin (IL)-17 receptor A, thereby inhibiting several pro-inflammatory cytokines from the IL-17 family. Regulatory applications for brodalumab in plaque psoriasis are also under review in the USA, EU and Canada. This article summarizes the milestones in the development of brodalumab leading to this first approval for the treatment of psoriasis. PMID:27577550

  19. The changing environment for US pharmaceuticals.

    PubMed

    Meyer, P R

    1994-01-01

    Health reform is currently the predominant health policy issue in the US. It carries profound implications for the pharmaceutical field, including the possibility of price controls that could stifle pharmaceutical research. While policy makers are contemplating alternative approaches to reform, the marketplace for pharmaceuticals has changed dramatically. For example, price increases have lessened, price discounting has increased, and new drugs are typically launched at prices lower than those of the leading product in the therapeutic class. These changes are driven in part by the growth of managed care. Further evidence of change in the industry is the number of job reductions announced and the decline in market valuation of pharmaceutical companies. Policy makers need to take the changed marketplace into consideration as they proceed with health reform, to avoid layering additional policy impediments on top of an increasingly harsh and unforgiving market. Such an approach could seriously compromise incentives for pharmaceutical research. PMID:10155590

  20. Pharmaceutical counterfeiting and the RFID technology intervention.

    PubMed

    Coustasse, Alberto; Arvidson, Cody; Rutsohn, Phil

    2010-07-01

    Both nationally and internationally, pharmaceutical counterfeiting has become a problem that is threatening economic stability and public health. The purpose of the present research study review was to analyze the scope and severity of pharmaceutical counterfeiting and to establish if the implantation of the Radio Frequency Identification Device (RFID) model can more efficiently be used within the pharmaceutical supply chain to reduce the problem counterfeit drugs impose on public health and international economic stability. Results indicated that implementing the RFID model for tracking drugs at the item level in the pharmaceutical supply chain has potential to alleviate the scope of the counterfeit drug problem. Recommendations for how the pharmaceutical industry may sooner adopt the RFID model are made. PMID:20582850

  1. Developing a pharmaceutical purchasing strategy.

    PubMed

    Hynniman, C E

    1992-09-01

    The process commonly used by group purchasing organizations to contract for multisource pharmaceuticals and a strategic approach for the director of pharmacy in working with the purchasing group and the P & T Committee is described. The pharmacist should be knowledgeable concerning the group's contract commitment requirements, product specifications, terms and conditions and procedures for vendor selection, product award, contract implementation, and performance monitoring. To ensure results that meet the needs of the medical staff, it is important that the P & T Committee actively participate. The P & T Committee should understand the reasons for selecting a particular purchasing group, understand the necessary steps in obtaining the most favorable economic advantage, review products with potential brand interchange concerns, recommend product specifications, and reaffirm formulary procedures regarding the principle of current consent. PMID:10171225

  2. The template update problem.

    PubMed

    Matthews, Iain; Ishikawa, Takahiro; Baker, Simon

    2004-06-01

    Template tracking dates back to the 1981 Lucas-Kanade algorithm. One question that has received very little attention, however, is how to update the template so that it remains a good model of the tracked object. We propose a template update algorithm that avoids the "drifting" inherent in the naive algorithm. PMID:18579941

  3. Country Update: Israel 2005

    ERIC Educational Resources Information Center

    Marar, Marianne Maurice

    2005-01-01

    Country Updates is a new section of "Intercultural Education." Starting in "Intercultural Education," Volume 16 No. 5, this column will focus on recent developments during the last two to three years in the field of intercultural education in one particular country. These updates can include recent policy decisions, the main results of important…

  4. Approval tests and standards for closed-circuit escape respirators. Final rule.

    PubMed

    2012-03-01

    This final rule announces updated requirements that the National Institute for Occupational Safety and Health (NIOSH or Agency), located within the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS or Department), will employ to test and approve closed-circuit respirators used for escaping atmospheres considered to be immediately dangerous to life and health, including such respirators required by the Mine Safety and Health Administration (MSHA) for use in underground coal mines. NIOSH and MSHA jointly review and approve this type of respirator used for mine emergencies under regulations concerning approval of respiratory protective devices. NIOSH also approves these respirators for use in other work environments where escape equipment may be provided to workers, such as on vessels operated by U.S. Navy and Coast Guard personnel. The purpose of these updated requirements is to enable NIOSH and MSHA to more effectively ensure the performance, reliability, and safety of CCERs. PMID:22420059

  5. GI Course Approvals.

    ERIC Educational Resources Information Center

    Orlans, Harold; And Others

    The process by which institutions and courses are approved for veterans educational benefits is examined in this study mandated by Public Law 95-202. The legislative background of the investigation is described as well as the history of the Servicemen's Readjustment Act of 1944, the Korean Bill of 1952, and P.L. 94-502 of 1976. A summary guide to…

  6. FDA Approval for Imiquimod

    Cancer.gov

    On July 15, 2004, the U.S. Food and Drug Administration (FDA) announced the approval of a new indication for Aldara® (imiquimod) topical cream for the treatment of superficial basal cell carcinoma (sBCC), a type of skin cancer.

  7. Venetoclax: First Global Approval.

    PubMed

    Deeks, Emma D

    2016-06-01

    Venetoclax (Venclexta™) is an oral selective inhibitor of the prosurvival protein BCL-2 and therefore restores the apoptotic ability of malignant cells. The drug arose from research by Abbott Laboratories (now AbbVie) during a collaboration with Genentech and is being co-developed by AbbVie and Genentech/Roche primarily for the treatment of haematological malignancies. Venetoclax is approved in the USA for use as monotherapy in patients with chronic lymphocytic leukaemia (CLL) with the 17p deletion (as detected by an approved FDA test) who have received at least one prior therapy, and is awaiting approval for similar indications in the EU and Canada. Venetoclax is also in phase I-III development as combination therapy for CLL, phase I/II development as monotherapy and/or combination therapy for non-Hodgkin lymphomas (including diffuse large B-cell lymphoma, mantle cell lymphoma, follicular lymphoma) and acute myeloid leukaemia, and phase I development for multiple myeloma, systemic lupus erythematosus and breast cancer. This article summarizes the milestones in the development of venetoclax leading to this first approval for CLL. PMID:27260335

  8. 75 FR 64953 - Approval and Promulgation of Implementation Plans; State of Missouri

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-21

    ...EPA is approving a revision to a State Implementation Plan (SIP) submitted by the State of Missouri. The purpose of this revision is to update the Springfield City Code and is part of ongoing SIP maintenance to assure that outdated local codes and ordinances do not remain in the SIP. The revision reflects updates to the Missouri statewide rules, and will ensure consistency between the......

  9. Organic herbicide update

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Weed research is the top research priority among organic producers. Very few chemical weed control options are approved for organic use (corn gluten meal, vinegar, clove oil, and most recently ammonium pelargonate ), but additional compounds are under investigation and pursuing organic approval. C...

  10. A harmonization effort for acceptable daily exposure application to pharmaceutical manufacturing - Operational considerations.

    PubMed

    Hayes, Eileen P; Jolly, Robert A; Faria, Ellen C; Barle, Ester Lovsin; Bercu, Joel P; Molnar, Lance R; Naumann, Bruce D; Olson, Michael J; Pecquet, Alison M; Sandhu, Reena; Shipp, Bryan K; Sussman, Robert G; Weideman, Patricia A

    2016-08-01

    A European Union (EU) regulatory guideline came into effect for all new pharmaceutical products on June 1st, 2015, and for all existing pharmaceutical products on December 1st, 2015. This guideline centers around the use of the Acceptable Daily Exposure (ADE) [synonymous with the Permitted Daily Exposure (PDE)] and operational considerations associated with implementation are outlined here. The EU guidance states that all active pharmaceutical ingredients (API) require an ADE; however, other substances such as starting materials, process intermediates, and cleaning agents may benefit from an ADE. Problems in setting ADEs for these additional substances typically relate to toxicological data limitations precluding the ability to establish a formal ADE. Established methodologies such as occupational exposure limits or bands (OELs or OEBs) and the threshold of toxicological concern (TTC) can be used or adjusted for use as interim ADEs when only limited data are available and until a more formal ADE can be established. Once formal ADEs are derived, it is important that the documents are routinely updated and that these updates are communicated to appropriate stakeholders. Another key operational consideration related to data-poor substances includes the use of maximum daily dose (MDD) in setting cross-contamination limits. The MDD is an important part of the maximum allowable/safe concentration (MAC/MSC) calculation and there are important considerations for its use and definition. Finally, other considerations discussed include operational aspects of setting ADEs for pediatrics, considerations for large molecules, and risk management in shared facilities. PMID:27267172

  11. Genomics and Health Impact Update

    MedlinePlus

    ... Genomics in Practice Newborn Screening Pharmacogenomics Reproductive Health Tools and Databases About the Genomics & Health Impact Update The Office of Public Health Genomics provides updated and credible ...

  12. Pharmaceutical aspects of anti-inflammatory TNF-blocking drugs.

    PubMed

    Jinesh, Sandhya

    2015-06-01

    Tumor necrosis factor (TNF) is a key regulator of inflammatory processes in several immune-mediated inflammatory diseases such as rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriasis and psoriatic arthritis. Inactivating TNF has been found to be a plausible approach in treating these conditions. Two major strategies have been adopted by scientists to inactivate TNF: one is to use monoclonal antibodies (mAbs) that bind to TNF, and the other is to use fusion proteins that bind to TNF, both inactivate TNF and help to prevent TNF-mediated inflammatory processes. Monoclonal antibodies (mAbs) are biological products that selectively bind to specific antigen molecules, and fusion proteins are soluble receptors that bind to TNF. These types of drugs are generally known as biologics and there has been an explosion in the development and testing of biologics since the 1994 US approval and launch of abciximab, a mAb that binds to GPIIb/IIIa on platelets. Anti-TNF drugs that are currently approved by FDA for treating inflammatory conditions include adalimumab, certolizumab pegol, golimumab, infliximab and etanercept. Since these agents are complex protein molecules, the pharmacodynamics and pharmacokinetics of these drugs are different from small-molecule anti-inflammatory agents. This review focuses on the pharmaceutical aspects of these drugs such as mechanism of action, adverse effects, pharmacokinetics and drug interactions. An effort was also taken to compare the pharmacodynamics and pharmacokinetic properties of these drugs, with the available data at this time. PMID:25687751

  13. Position and enforcement practice of the People’s Republic of China’s pharmaceutical data exclusivity protection

    PubMed Central

    Li, Na; Yu, Xiang; Pecht, Michael

    2016-01-01

    The concept of pharmaceutical data exclusivity protection comes from the West. The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) establishes the basic rules for pharmaceutical data exclusivity protection. People’s Republic of China’s domestic law is consistent with the TRIPS agreement. In the drug registration approval process of the People’s Republic of China’s Drug Supervision Department, pharmaceutical data exclusivity protection has encountered some problems, including data authentication, exclusive rights to data, number of drugs requiring data to be submitted, and drug costs. In view of the long-term interests of the People’s Republic of China’s pharmaceutical industry and intellectual property protection trends, there are a lot of difficulties in the enforcement of pharmaceutical data exclusivity protection law that need to be overcome. Some measures can be taken, such as establishing a shorter data exclusivity protection period, only protecting the data submitted and relied on in the People’s Republic of China, only protecting the drugs that use new chemical components, allowing application and necessary research before the expiry of pharmaceutical data exclusivity protection period of generic drugs. PMID:27382254

  14. Self-regulatory codes of conduct: are they effective in controlling pharmaceutical representatives' presentations to general medical practitioners?

    PubMed

    Roughead, E E; Gilbert, A L; Harvey, K J

    1998-01-01

    Self-regulatory codes of conduct are used to control the promotional practices of the pharmaceutical industry, but the effectiveness of these codes in controlling pharmaceutical representatives' presentations has not been examined. This is a matter of concern because pharmaceutical representatives have more influence than any other promotional media on prescribing practices. The authors developed a method for monitoring the oral presentations of pharmaceutical representatives when promoting products to medical practitioners. Sixteen audio-recordings, detailing 64 medicines, were obtained; 38 of the 64 products were prescription-only medicines. Information on indications and on dosage and administration was commonly provided, but information on other areas of drug knowledge, particularly product risk, was minimal. Thirteen presentations contained at least one inaccuracy when compared with Australian Approved Product Information. Presentations did not always comply with current guidelines in the Code of Conduct. The Code provides only limited standards for pharmaceutical representatives' presentations, and no active monitoring system is in place to ensure adherence to the code. There is an urgent need for policy development on the role of pharmaceutical representatives, their standards of practice, and regulation of their activities to ensure they contribute to the appropriate use of medicines. PMID:9595344

  15. Vulnerabilities to misinformation in online pharmaceutical marketing

    PubMed Central

    De Freitas, Julian; Falls, Brian A; Haque, Omar S; Bursztajn, Harold J

    2013-01-01

    Given the large percentage of Internet users who search for health information online, pharmaceutical companies have invested significantly in online marketing of their products. Although online pharmaceutical marketing can potentially benefit both physicians and patients, it can also harm these groups by misleading them. Indeed, some pharmaceutical companies have been guilty of undue influence, which has threatened public health and trust. We conducted a review of the available literature on online pharmaceutical marketing, undue influence and the psychology of decision-making, in order to identify factors that contribute to Internet users’ vulnerability to online pharmaceutical misinformation. We find five converging factors: Internet dependence, excessive trust in the veracity of online information, unawareness of pharmaceutical company influence, social isolation and detail fixation. As the Internet continues to change, it is important that regulators keep in mind not only misinformation that surrounds new web technologies and their contents, but also the factors that make Internet users vulnerable to misinformation in the first place. Psychological components are a critical, although often neglected, risk factor for Internet users becoming misinformed upon exposure to online pharmaceutical marketing. Awareness of these psychological factors may help Internet users attentively and safely navigate an evolving web terrain. PMID:23761527

  16. Vulnerabilities to misinformation in online pharmaceutical marketing.

    PubMed

    De Freitas, Julian; Falls, Brian A; Haque, Omar S; Bursztajn, Harold J

    2013-05-01

    Given the large percentage of Internet users who search for health information online, pharmaceutical companies have invested significantly in online marketing of their products. Although online pharmaceutical marketing can potentially benefit both physicians and patients, it can also harm these groups by misleading them. Indeed, some pharmaceutical companies have been guilty of undue influence, which has threatened public health and trust. We conducted a review of the available literature on online pharmaceutical marketing, undue influence and the psychology of decision-making, in order to identify factors that contribute to Internet users' vulnerability to online pharmaceutical misinformation. We find five converging factors: Internet dependence, excessive trust in the veracity of online information, unawareness of pharmaceutical company influence, social isolation and detail fixation. As the Internet continues to change, it is important that regulators keep in mind not only misinformation that surrounds new web technologies and their contents, but also the factors that make Internet users vulnerable to misinformation in the first place. Psychological components are a critical, although often neglected, risk factor for Internet users becoming misinformed upon exposure to online pharmaceutical marketing. Awareness of these psychological factors may help Internet users attentively and safely navigate an evolving web terrain. PMID:23761527

  17. Evolution of Plant-Made Pharmaceuticals

    PubMed Central

    Thomas, David R.; Penney, Claire A.; Majumder, Amrita; Walmsley, Amanda M.

    2011-01-01

    The science and policy of pharmaceuticals produced and/or delivered by plants has evolved over the past twenty-one years from a backyard remedy to regulated, purified products. After seemingly frozen at Phase I human clinical trials with six orally delivered plant-made vaccines not progressing past this stage over seven years, plant-made pharmaceuticals have made a breakthrough with several purified plant-based products advancing to Phase II trials and beyond. Though fraught with the usual difficulties of pharmaceutical development, pharmaceuticals made by plants have achieved pertinent milestones albeit slowly compared to other pharmaceutical production systems and are now at the cusp of reaching the consumer. Though the current economic climate begs for cautious investment as opposed to trail blazing, it is perhaps a good time to look to the future of plant-made pharmaceutical technology to assist in planning for future developments in order not to slow this technology’s momentum. To encourage continued progress, we highlight the advances made so far by this technology, particularly the change in paradigms, comparing developmental timelines, and summarizing the current status and future possibilities of plant-made pharmaceuticals. PMID:21686181

  18. Drugs Approved for Lung Cancer

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Lung Cancer This page lists cancer ... in lung cancer that are not listed here. Drugs Approved for Non-Small Cell Lung Cancer Abitrexate ( ...

  19. Drugs Approved for Bladder Cancer

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Bladder Cancer This page lists cancer ... in bladder cancer that are not listed here. Drugs Approved for Bladder Cancer Atezolizumab Cisplatin Doxorubicin Hydrochloride ...

  20. Drugs Approved for Hodgkin Lymphoma

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Hodgkin Lymphoma This page lists cancer ... in Hodgkin lymphoma that are not listed here. Drugs Approved for Hodgkin Lymphoma Adcetris (Brentuximab Vedotin) Ambochlorin ( ...

  1. Drugs Approved for Pancreatic Cancer

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Pancreatic Cancer This page lists cancer ... in pancreatic cancer that are not listed here. Drugs Approved for Pancreatic Cancer Abraxane (Paclitaxel Albumin-stabilized ...

  2. Drugs Approved for Testicular Cancer

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Testicular Cancer This page lists cancer ... in testicular cancer that are not listed here. Drugs Approved for Testicular Cancer Blenoxane (Bleomycin) Bleomycin Cisplatin ...

  3. Drugs Approved for Malignant Mesothelioma

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Malignant Mesothelioma This page lists cancer ... in malignant mesothelioma that are not listed here. Drugs Approved for Malignant Mesothelioma Alimta (Pemetrexed Disodium) Pemetrexed ...

  4. Drugs Approved for Vulvar Cancer

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Vulvar Cancer This page lists cancer ... in vulvar cancer that are not listed here. Drugs Approved to Prevent Vulvar Cancer Gardasil (Recombinant HPV ...

  5. Drugs Approved for Cervical Cancer

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Cervical Cancer This page lists cancer ... in cervical cancer that are not listed here. Drugs Approved to Prevent Cervical Cancer Cervarix (Recombinant HPV ...

  6. Drugs Approved for Skin Cancer

    MedlinePlus

    ... Professionals Questions to Ask about Your Treatment Research Drugs Approved for Skin Cancer This page lists cancer ... in skin cancer that are not listed here. Drugs Approved for Basal Cell Carcinoma Aldara (Imiquimod) Efudex ( ...

  7. Is It Really FDA Approved?

    MedlinePlus

    ... and implantable infusion pumps, require FDA approval before marketing. To receive FDA approval for these devices, the ... and many types of catheters) are cleared for marketing based on an FDA determination that they are ...

  8. Another development in pharmaceuticals: an introduction.

    PubMed

    Streky, G

    1985-01-01

    The provision of appropriate medicines of the right kind, quality and quantity, and at reasonable prices is a central concern for any government. Simultaneously, there is increasing recognition of the serious problems inherent in the existing systems of pharmaceutical development, promotion, marketing, distribution and use in all countries and particularly in the 3rd World. The vast majority of people in most 3rd World countries have little or no access to effective and safe medicines. The Dag Hammarskjold Foundation organized a consultation on Another Development in Pharmaceuticals in June 1985. It was based on some papers commissioned for that occasion with a view to developing new approaches to fundamental problems in this field and involving both national and international actors and institutions. The basic concern of these papers was to place the debate on pharmaceuticals in its proper historical, contemporary and future context. The 5 major areas discussed were: 1) man and medicines: a historical perspective; 2) towards a healthy use of pharmaceuticals; 3) towards a healthy pharmaceutical industry by the year 2000; 4) 1st principles for the prescription, promotion and use of pharmaceuticals: towards a code of conduct; and 5) monitoring Another Development in Pharmaceuticals. 90% of the world's production of pharmaceuticals originates in the industrialized countries, which also accounts for 80% of the consumption. 3rd World countries have been supplied with a very inappropriate assortment of products by the pharmaceutical industry. There is a growing demand for improved practices that are conducive to health development. An international harmonization of regulatory standards is needed. PMID:12341048

  9. Medical Students' Exposure to and Attitudes about the Pharmaceutical Industry: A Systematic Review

    PubMed Central

    Austad, Kirsten E.; Avorn, Jerry; Kesselheim, Aaron S.

    2011-01-01

    Background The relationship between health professionals and the pharmaceutical industry has become a source of controversy. Physicians' attitudes towards the industry can form early in their careers, but little is known about this key stage of development. Methods and Findings We performed a systematic review reported according to PRISMA guidelines to determine the frequency and nature of medical students' exposure to the drug industry, as well as students' attitudes concerning pharmaceutical policy issues. We searched MEDLINE, EMBASE, Web of Science, and ERIC from the earliest available dates through May 2010, as well as bibliographies of selected studies. We sought original studies that reported quantitative or qualitative data about medical students' exposure to pharmaceutical marketing, their attitudes about marketing practices, relationships with industry, and related pharmaceutical policy issues. Studies were separated, where possible, into those that addressed preclinical versus clinical training, and were quality rated using a standard methodology. Thirty-two studies met inclusion criteria. We found that 40%–100% of medical students reported interacting with the pharmaceutical industry. A substantial proportion of students (13%–69%) were reported as believing that gifts from industry influence prescribing. Eight studies reported a correlation between frequency of contact and favorable attitudes toward industry interactions. Students were more approving of gifts to physicians or medical students than to government officials. Certain attitudes appeared to change during medical school, though a time trend was not performed; for example, clinical students (53%–71%) were more likely than preclinical students (29%–62%) to report that promotional information helps educate about new drugs. Conclusions Undergraduate medical education provides substantial contact with pharmaceutical marketing, and the extent of such contact is associated with positive

  10. Managing the cost of specialty pharmaceuticals.

    PubMed

    Kernich, Catherine A; Creighton, Frederick A

    2004-01-01

    The cost of specialty pharmaceuticals is a significant driver of increased costs in the delivery of ambulatory care. This expense is expected to increase disproportionately as an increased number of specialty pharmaceuticals available to treat rare, complex, or chronic diseases enter the market. Ambulatory practice managers must plan for these increased expenditures in a fiscally sound manner. The department of medicine at University Hospitals of Cleveland has developed a comprehensive system of checks and balances for managing specialty pharmaceuticals. This system includes working closely with providers and payers, underpinned with sound business planning techniques. PMID:15586478

  11. Proposing a redefinition of pharmaceutical care.

    PubMed

    Blackburn, David F; Yakiwchuk, Erin M; Jorgenson, Derek J; Mansell, Kerry D

    2012-03-01

    In many clinical practice settings, individual pharmaceutical care practitioners have thousands of patients who may receive their service. However, the pharmaceutical care approach provides virtually no guidance regarding how patients should be identified or prioritized by practicing pharmacists. We believe that pharmacists need to be "officially" accountable to specific patient groups at high risk for drug- or disease-induced morbidity within their practice. Consequently, the current definition of pharmaceutical care and its associated care processes need to be modified to ensure the activities of pharmacists are being focused on high-priority patients on a consistent basis. PMID:22395251

  12. Metrology in Pharmaceutical Industry - A Case Study

    NASA Astrophysics Data System (ADS)

    Yuvamoto, Priscila D.; Fermam, Ricardo K. S.; Nascimento, Elizabeth S.

    2016-07-01

    Metrology is recognized by improving production process, increasing the productivity, giving more reliability to the measurements and consequently, it impacts in the economy of a country. Pharmaceutical area developed GMP (Good Manufacture Practice) requeriments, with no introduction of metrological concepts. However, due to Nanomedicines, it is expected this approach and the consequent positive results. The aim of this work is to verify the level of metrology implementation in a Brazilian pharmaceutical industry, using a case study. The purpose is a better mutual comprehension by both areas, acting together and governmental support to robustness of Brazilian pharmaceutical area.

  13. Update on medicines for smoking cessation

    PubMed Central

    McDonough, Mike

    2015-01-01

    Summary Persistent cigarette smokers usually have a nicotine addiction. This addiction has a chronic relapsing and sometimes remitting course and may persist lifelong. Remission can be facilitated by the use of medication as part of a comprehensive management strategy tailored to the individual patient. Nicotine replacement therapy is a first-line drug treatment. It is available in many formulations. Varenicline is also a first-line drug treatment. It should be started before the patient stops smoking. Bupropion is a second-line therapy. It may be associated with an increased risk of seizures and drug interactions. While there is some evidence that electronic cigarettes might facilitate smoking cessation, quit rates are not yet comparable with those of the drugs approved on the Pharmaceutical Benefits Scheme. PMID:26648633

  14. Cariprazine: First Global Approval.

    PubMed

    McCormack, Paul L

    2015-11-01

    Cariprazine (Vraylar) is an oral atypical antipsychotic originated by Gedeon Richter. It is a potent dopamine D3 and D2 receptor partial agonist, which preferentially binds to the D3 receptor. Cariprazine also has partial agonist activity at serotonin 5-HT1A receptors. In September 2015, cariprazine received its first global approval in the USA for the treatment of schizophrenia and for the acute treatment of manic or mixed episodes associated with bipolar I disorder. It is also in development in a variety of countries for the treatment of schizophrenia with predominant negative symptoms (phase III), as adjunctive therapy for major depressive disorder (phase II/III) and for the treatment of bipolar depression (phase II). This article summarizes the milestones in the development of cariprazine leading to this first approval for schizophrenia and manic or mixed episodes associated with bipolar I disorder. PMID:26510944

  15. Cobimetinib: First Global Approval.

    PubMed

    Garnock-Jones, Karly P

    2015-10-01

    Genentech (a subsidiary of Roche) and Exelixis are developing cobimetinib, an orally available small molecule, for the treatment of various cancers, including malignant melanoma and breast cancer. Cobimetinib inhibits the MEK (mitogen-activated protein kinase) component of the MAPK/ERK signalling pathway, which is frequently over-activated in human tumours. The product has been approved in Switzerland in combination with vemurafenib for the treatment of patients with unresectable or metastatic BRAF V600 mutation-positive melanoma, and is under regulatory review for the same indication in several countries, including the USA and the EU. This article summarizes the milestones in the development of cobimetinib leading to this first approval for unresectable or metastatic BRAF V600 mutation-positive melanoma melanoma. PMID:26452567

  16. A new reimbursement system for innovative pharmaceuticals combining value-based and free market pricing.

    PubMed

    Persson, Ulf; Svensson, Johanna; Pettersson, Billie

    2012-07-01

    Sweden has experienced a national value-based pricing (VBP) system for innovative outpatient drugs operated by the Pharmaceutical Benefits Board - LFN (now called the Dental and Pharmaceutical Benefits agency - TLV) since 2002. VBP has the character of a monopoly system, leading to reimbursement decisions where usage of new medicines is limited to subgroups and not the population for which the drug is approved. VBP relies on a broad societal perspective, encouraging innovations by signaling to firms that value-adding treatments are demanded. However, the VBP system is operated without a drug budget responsibility. The budget responsibility lies at the regional level, not operating VBP, thus an intrinsic conflict is built into the system. The aim of this article is to suggest a modification to the current reimbursement system in Sweden where payment for pharmaceuticals is split between the regional and national levels. The system is expected to make new innovative pharmaceuticals accessible to a larger number of patients and provide more consumer surplus without reducing the producer surplus. In short, the county councils pay the marginal cost of production while the state pays for the innovation. PMID:22676213

  17. Obiltoxaximab: First Global Approval.

    PubMed

    Greig, Sarah L

    2016-05-01

    Obiltoxaximab (Anthim(®), ETI-204) is a monoclonal antibody that is being developed by Elusys Therapeutics and the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority for the prevention and treatment of inhalational anthrax due to Bacillus anthracis. Obiltoxaximab has been designed to neutralize the free protective antigen of B. anthracis, thereby inhibiting the lethal effects of anthrax toxins. In March 2016, intravenous obiltoxaximab was approved in the USA for the treatment (in combination with appropriate antibacterial drugs) and prophylaxis of inhalational anthrax. Obiltoxaximab is being developed under the US FDA Animal Rule, in which marketing approval is based on its efficacy in relevant animal models and safety in phase I studies in healthy human volunteers. An intramuscular formulation of obiltoxaximab has also been evaluated in animal studies and a phase I study in healthy human volunteers. This article summarizes the milestones in the development of obiltoxaximab leading to this first approval for the treatment and prevention of inhalation anthrax. PMID:27085536

  18. Osimertinib: First Global Approval.

    PubMed

    Greig, Sarah L

    2016-02-01

    Osimertinib (Tagrisso(™), AZD9291) is an oral, third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that is being developed by AstraZeneca for the treatment of advanced non-small cell lung cancer (NSCLC). Osimertinib has been designed to target the EGFR T790M mutation that is often present in NSCLC patients with acquired EGFR TKI resistance, while sparing wild-type EGFR. In November 2015, the tablet formulation of osimertinib was granted accelerated approval in the USA for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC (as detected by an FDA-approved test) who have progressed on or after EGFR TKI therapy. Osimertinib has also been granted accelerated assessment status for this indication in the EU, and is in phase III development for first- and second-line and adjuvant treatment of advanced EGFR mutation-positive NSCLC in several countries. Phase I trials in patients with advanced solid tumours are also being conducted. This article summarizes the milestones in the development of osimertinib leading to this first approval for NSCLC. PMID:26729184

  19. Tasimelteon: first global approval.

    PubMed

    Dhillon, Sohita; Clarke, Madeleine

    2014-03-01

    Tasimelteon (HETLIOZ™) is an orally bioavailable agonist of the melatonin MT1 and MT2 receptors that has been approved in the US for the treatment of non-24-hour sleep-wake disorder. It is the first US FDA-approved medication for this orphan indication. Melatonin is thought to play a role in governing the body's natural sleep-wake cycle through physiological processes regulated in the suprachiasmatic nucleus of the hypothalamus. The hormone is secreted by the pineal gland, with onset typically occurring when daylight begins to dim. In healthy, sighted individuals, the endogenous circadian period is a little over 24 hours, but is entrained to the 24-hour day through exposure to environmental cues, such as light and darkness. In the absence of these cues, synchronisation is lost and the circadian rhythm follows the intrinsic non-24-hour clock, resulting in disorders like non-24-hour sleep-wake disorder. Because the rhythm of endogenous melatonin is considered to be a measure of the human circadian phase, the carefully timed administration of melatonin analogues, such as tasimelteon, can potentially promote circadian readjustment. This article summarizes the milestones in the development of tasimelteon leading to this first approval for the treatment of non-24-hour sleep-wake disorder. PMID:24610704

  20. Vortioxetine: first global approval.

    PubMed

    Gibb, Andrew; Deeks, Emma D

    2014-01-01

    Vortioxetine is an orally administered small molecule developed by Lundbeck A/S for the once-daily treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD). Vortioxetine received its first global approval for MDD in the USA in September 2013 and regulatory approval for its use in this indication in the EU (where it has received a positive opinion) and Canada is awaited. The drug is a bis-aryl-sulphanyl amine compound that combines serotonin (5-HT) reuptake inhibition with other characteristics, including receptor activity modulation. In vitro studies indicate that vortioxetine is an inhibitor of the 5-HT transporter and is a 5-HT(1D), 5-HT₃ and 5-HT₇ receptor antagonist, a 5-HT(1A) receptor agonist and a 5-HT(1B) receptor partial agonist. Animal and in vitro studies indicate that several neurotransmitter systems may be impacted by vortioxetine, with the drug enhancing levels of 5-HT, noradrenaline, dopamine, acetylcholine and histamine in certain areas of the brain, as well as modulating γ-aminobutyric acid and glutamate neurotransmission. Phase III trials of vortioxetine in both MDD and GAD have been conducted worldwide. This article summarizes the milestones in the development of vortioxetine leading to this first approval for MDD. PMID:24311349

  1. Pharmaceutical standardization of Apamarga kshara

    PubMed Central

    Jadav, Hasmukh R.; Galib, R.; Prajapati, Pradeep Kumar

    2015-01-01

    Standardization of herbal drugs is essential to certify their quality and purity. Kshara (alkaline substance) of Apamarga (Achyranthes aspera Linn.) is an important constituent in many Ayurvedic formulations, but its standard manufacturing process (SMP) is not attempted till date. This study is aimed to establish SMP for Apamarga kshara. In pharmaceutical process; generally the sediments of ash obtained at the end of washes will be discarded. However, in the study, we attempted to wash the sediments repeatedly by adding water to extract more Kshara. Apamarga was collected from the local area and authenticated. Kshara was prepared by following standard methods and the preliminary physicochemical profile was developed. It is observed that the ash yields Kshara even in the consecutive washes. First wash yielded 21.23% w/w Kshara, while the second and third washes yielded 9.38% w/w and 4.76% w/w, respectively. Repeated washes yield more Kshara. Hence, it is advocated to wash the ashes repeatedly. As the findings are encouraging, similar experiments can be extended to all other Kshara preparations. PMID:26834430

  2. Pharmacogenetics and the pharmaceutical industry.

    PubMed

    Raaijmakers, Jan A M; Koster, Ellen S; Maitland-van der Zee, Anke-Hilse

    2010-01-01

    The detailed knowledge of the human genome has not fulfilled its promise as yet. It seems fair to say that we are far from treating existing diseases by therapeutic interventions developed on the basis of genetic knowledge. However, pharmacogenetics has shown to be useful in improving our understanding of pharmacotherapy. Industry is starting to embed this knowledge in the design of innovative drugs and there are three important areas of interest: safety, efficacy and target identification. Application of pharmacogenetics e.g. in patient selection are leading to the direction of more personalised medicine. The future will bring more of such applications. However, current knowledge also leads to a more integrated approach of pharmacogenetics as part of systems biology, providing an even more complete image of reality surrounding disease and therapy, including for example environmental factors and behaviour. In addition, collaborative efforts with academic partners are very much welcomed by the pharmaceutical industry and are expected to have a synergistic effect on progression in this field. PMID:20205665

  3. New insights in pharmaceutical analysis.

    PubMed

    Guillarme, Davy; Schappler, Julie; Boccard, Julien; Veuthey, Jean-Luc; Rudaz, Serge

    2012-01-01

    The research unit of pharmaceutical analytical chemistry (PAC) has been active in the field of separation sciences for many years. Liquid chromatography (LC) and its latest improvements such as ultra-high performance chromatography (UHPLC) and supercritical fluid chromatography (SFC) are deeply and thoroughly studied, from a fundamental viewpoint to its various application capabilities. Electro-driven separations such as capillary electrophoresis (CE) are also a major field of interest, especially for macromolecules, and low cost. All these techniques are investigated with various detection modes including mass spectrometry (MS) for various applications where high sensitivity and selectivity is needed. Extracting the relevant information from the overwhelming amount of data generated by modern analytical platforms has become an important issue for knowledge discovery in various research fields. The appropriate treatment of such data is therefore of crucial importance to provide valuable information. Numerous works in our research group have demonstrated the usefulness of statistical and mathematical methodologies to improve quality of the results. Therefore, well-established chemometric approaches (e.g. design of experiments, multivariate data analysis, etc.) are implemented to optimize the analytical process from method development to data analysis. PMID:22867546

  4. Indigenous and multinational pharmaceutical companies.

    PubMed

    Lilja, J

    1983-01-01

    There is a set of complex relationships between governments and the pharmaceutical companies. These relationships can be analysed in many different ways. In the following article the drug system of each country will be the unit of analysis. The drug system includes all the decision processes, formal as well as informal, from the production or importation of drugs to the intake of the drug by the patient. The aim of this paper is to discuss how environmental factors, the strategies of the drug companies and the national policies, will effect the drug system of a country. Satisfying solutions to the economical and health goals of the country will be searched for. If we want a more rational discussion in this area, professionally and politically, we need more empirical knowledge about the multinational drug companies and their effects on society. This does not mean that we shall sit waiting for this new knowledge. We have to make decisions using todays knowledge. However, in the long run rational decision strategy must include ways to collect important empirical data about the phenomenom under investigation. The aim of this survey is to indicate areas where we already have quite good knowledge and indicate other areas where this data is missing. PMID:6623122

  5. ISS Update: Suitport Testing

    NASA Video Gallery

    ISS Update commentator Lynnette Madison interviews Joel Maganza, Test Director, about thermal vacuum chambers and unmanned and human-testing with the Suitport. Questions? Ask us on Twitter @NASA_Jo...

  6. ISS Update: NEEMO 16

    NASA Video Gallery

    ISS Update commentator Josh Byerly interviews astronaut Stan Love about the NEEMO 16 mission from Aquarius Base. Questions? Ask us on Twitter @NASA_Johnson and include the hashtag #askStation. For ...

  7. Paying for On-Patent Pharmaceuticals

    PubMed Central

    Goldfield, Norbert

    2016-01-01

    In this article we propose a new approach to pricing for patent-protected (on-patent) pharmaceuticals. We describe and define limit pricing as a method for drug companies to maximize revenue for their investment by offering budget-neutral pricing to encourage early adoption by payers. Under this approach, payers are incentivized to adopt innovative but expensive drugs more quickly if drug companies provide detailed analyses of the net impact of the new pharmaceutical upon total health budgets. For payers to adopt use of a new pharmaceutical, they would require objective third-party evaluation and pharmaceutical manufacturer accountability for projected outcomes efficacy of their treatments on population health. The pay for outcomes underpinning of this approach falls within the wider aspirations of health reform. PMID:26945298

  8. MULTIFUNCTIONAL AND STIMULI-SENSITIVE PHARMACEUTICAL NANOCARRIERS

    PubMed Central

    Torchilin, Vladimir

    2011-01-01

    Currently used pharmaceutical nanocarriers, such as liposomes, micelles, and polymeric nanoparticles, demonstrate a broad variety of useful properties, such as longevity in the body; specific targeting to certain disease sites; enhanced intracellular penetration; contrast properties allowing for direct carrier visualization in vivo; stimili-sensitivity, and others. Some of those pharmaceutical carriers have already made their way into clinic, while others are still under preclinical development. In certain cases, the pharmaceutical nanocarriers combine several of the listed properties. Long-circulating immunoliposomes capable of prolonged residence in the blood and specific target recognition represent one of examples of this kind. The engineering of multifunctional pharmaceutical nanocarriers combining several useful properties in one particle can significantly enhance the efficacy of many therapeutic and diagnostic protocols. This paper considers the current status and possible future directions in the emerging area of multifunctional nanocarriers with primary attention on the combination of such properties as longevity, targetability, intracellular penetration, contrast loading, and stimuli sensitivity. PMID:18977297

  9. Information flow in the pharmaceutical supply chain.

    PubMed

    Yousefi, Nazila; Alibabaei, Ahmad

    2015-01-01

    Managing the supply chain plays an important role in creating competitive advantages for companies. Adequate information flow in supply chain is one of the most important issues in SCM. Therefore, using certain Information Systems can have a significant role in managing and integrating data and information within the supply chain. Pharmaceutical supply chain is more complex than many other supply chains, in the sense that it can affect social and political perspectives. On the other hand, managing the pharmaceutical supply chain is difficult because of its complexity and also government regulations in this field. Although, Iran has progressed a lot in pharmaceutical manufacturing, still there are many unsolved issues in managing the information flow in the pharmaceutical supply chain. In this study, we reviewed the benefits of using different levels of an integrated information system in the supply chain and the possible challenges ahead. PMID:26664401

  10. Assessing the assessments: Pharmaceuticals in the environment

    SciTech Connect

    Enick, O.V. Moore, M.M.

    2007-11-15

    The relatively new issue of pharmaceutical contamination of the environment offers the opportunity to explore the application of values to the construction, communication and management of risk. The still-developing regulatory policies regarding environmental contamination with pharmaceuticals provide fertile ground for the introduction of values into the definition and management of risk. In this report, we summarize the current knowledge regarding pharmaceutical contamination of the environment and discuss specific attributes of pharmaceuticals that require special consideration. We then present an analysis showing that if values are incorporated into assessing, characterizing and managing risk, the results of risk assessments will more accurately reflect the needs of various stakeholders. Originating from an acknowledgement of the inherent uncertainty and value-laden nature of risk assessment, the precautionary principle (and later, the multi-criteria, integrated risk assessment), provides a direction for further research and policy development.

  11. Information flow in the pharmaceutical supply chain

    PubMed Central

    Yousefi, Nazila; Alibabaei, Ahmad

    2015-01-01

    Managing the supply chain plays an important role in creating competitive advantages for companies. Adequate information flow in supply chain is one of the most important issues in SCM. Therefore, using certain Information Systems can have a significant role in managing and integrating data and information within the supply chain. Pharmaceutical supply chain is more complex than many other supply chains, in the sense that it can affect social and political perspectives. On the other hand, managing the pharmaceutical supply chain is difficult because of its complexity and also government regulations in this field. Although, Iran has progressed a lot in pharmaceutical manufacturing, still there are many unsolved issues in managing the information flow in the pharmaceutical supply chain. In this study, we reviewed the benefits of using different levels of an integrated information system in the supply chain and the possible challenges ahead. PMID:26664401

  12. GUIDES TO POLLUTION PREVENTION: THE PHARMACEUTICAL INDUSTRY

    EPA Science Inventory

    Pharmaceutical manufacturers generate a variety of wastes during manufacturing, maintenance, and housekeeping operations which can be reduced or minimized through source reductIon and recycling. he typical waste streams are spent fermentation broths, process liquors, solvents, eq...

  13. Pharmaceutical marketing research and the prescribing physician.

    PubMed

    Greene, Jeremy A

    2007-05-15

    Surveillance of physicians' prescribing patterns and the accumulation and sale of these data for pharmaceutical marketing are currently the subjects of legislation in several states and action by state and national medical associations. Contrary to common perception, the growth of the health care information organization industry has not been limited to the past decade but has been building slowly over the past 50 years, beginning in the 1940s when growth in the prescription drug market fueled industry interest in understanding and influencing prescribing patterns. The development of this surveillance system was not simply imposed on the medical profession by the pharmaceutical industry but was developed through the interactions of pharmaceutical salesmen, pharmaceutical marketers, academic researchers, individual physicians, and physician organizations. Examination of the role of physicians and physician organizations in the development of prescriber profiling is directly relevant to the contemporary policy debate surrounding this issue. PMID:17502635

  14. Active Pharmaceutical Ingredients and Aquatic Organisms

    EPA Science Inventory

    The presence of active pharmaceuticals ingredients (APIs) in aquatic systems in recent years has led to a burgeoning literature examining environmental occurrence, fate, effects, risk assessment, and treatability of these compounds. Although APIs have received much attention as ...

  15. ENVIRONMENTAL STEWARDSHIP OF PHARMACEUTICALS - THE GREEN PHARMACY

    EPA Science Inventory

    The occurrence of pharmaceuticals and personal care products (PPCPS) as environmental pollutants is a multifaceted issue whose scope continues to become better delineated since the escalation of conceited attention beginning in the 1980s. PPCPs typically occur as trace environme...

  16. Agreements at the Pharmaceutical/University Interface.

    ERIC Educational Resources Information Center

    Ku, Katherine

    1987-01-01

    Specific agreements that arise at the interface between universities and pharmaceutical companies are described including sponsored research agreements, license agreements, clinical study agreements, material transfer agreements, and patient consent forms with respect to commercialization rights. (Author/MLW)

  17. Past, present and future of pharmaceutical patents under Korea-US Trade Agreement.

    PubMed

    Shin, Yoon Suk

    2016-07-01

    The introduction of substance patents in 1987 was viewed with apprehension as it was believed that the system would only reinforce the domination of the technology of advanced countries based on the trade agreement between Korea and the USA. However, substance patents provided the Korean pharmaceutical industry with the driving force required to develop new substances, and the Korean pharmaceutical industry has been constantly improving its research and development capability. The patent-approval linkage system was implemented according to the Korea-US Free Trade Agreement in 2015. The system comprises the following: registering the drugs in the Green List, notifying the listed patent and marketing approval holders about the application for generic marketing approval, patent holder's request for staying generic sales and first generic exclusivity. Korean generic companies are expected to have opportunities that enable them to challenge the global market by accumulating experience of designing of generic products, making patent challenges and strategically developing of new drugs or incrementally modified drugs through the linkage system. PMID:27338849

  18. THz spectroscopy: An emerging technology for pharmaceutical development and pharmaceutical Process Analytical Technology (PAT) applications

    NASA Astrophysics Data System (ADS)

    Wu, Huiquan; Khan, Mansoor

    2012-08-01

    As an emerging technology, THz spectroscopy has gained increasing attention in the pharmaceutical area during the last decade. This attention is due to the fact that (1) it provides a promising alternative approach for in-depth understanding of both intermolecular interaction among pharmaceutical molecules and pharmaceutical product quality attributes; (2) it provides a promising alternative approach for enhanced process understanding of certain pharmaceutical manufacturing processes; and (3) the FDA pharmaceutical quality initiatives, most noticeably, the Process Analytical Technology (PAT) initiative. In this work, the current status and progress made so far on using THz spectroscopy for pharmaceutical development and pharmaceutical PAT applications are reviewed. In the spirit of demonstrating the utility of first principles modeling approach for addressing model validation challenge and reducing unnecessary model validation "burden" for facilitating THz pharmaceutical PAT applications, two scientific case studies based on published THz spectroscopy measurement results are created and discussed. Furthermore, other technical challenges and opportunities associated with adapting THz spectroscopy as a pharmaceutical PAT tool are highlighted.

  19. Pharmaceutical published literature databases: a survey.

    PubMed

    Hull, P

    1996-01-01

    Pharmaceutical companies often maintain a bibliographic database of published articles on their products. Although such databases share the common purpose of providing the company with a centralized source of published information, the databases themselves vary in scope, uses, and technologies. In order to explore the current status of these databases, a survey was conducted in early 1995. This article provides an overview of pharmaceutical product literature databases and the results from that survey. PMID:10157847

  20. Evidence-based decision-making within Australia's pharmaceutical benefits scheme.

    PubMed

    Lopert, Ruth

    2009-07-01

    In Australia, most prescription drugs are subsidized through the Pharmaceutical Benefits Scheme (PBS), one of several government programs in which evidence-based decision making is applied to the funding of health technologies. PBS processes are intended to ensure "value for money" for the Australian taxpayer and to support affordable, equitable access to prescription medicines; they are not intended as a mechanism for cost containment. The inclusion of a drug on the national formulary depends on the recommendation of the Pharmaceutical Benefits Advisory Committee (PBAC), which considers not only the comparative effectiveness but also the comparative cost-effectiveness of drugs proposed for listing. While some decisions have been controversial, the PBS retains strong public support. Moreover, evidence does not suggest that the consideration of cost-effectiveness has created a negative environment for the drug industry: Australia has a high penetration of patented medicines, with prices for some recently approved drugs at U.S. levels. PMID:19639714

  1. Rejection of pharmaceuticals by forward osmosis membranes.

    PubMed

    Jin, Xue; Shan, Junhong; Wang, Can; Wei, Jing; Tang, Chuyang Y

    2012-08-15

    Rejection of four pharmaceutical compounds, carbamazepine, diclofenac, ibuprofen and naproxen, by forward osmosis (FO) membranes was investigated in this study. For the first time, the rejection efficiency of the pharmaceutical compounds was compared between commercial cellulose triacetate (CTA) based membranes and thin film composite (TFC) polyamide based membranes. The rejection behavior was related to membrane interfacial properties, physicochemical characteristics of the pharmaceutical molecules and feed solution pH. TFC polyamide membranes exhibited excellent overall performance, with high water flux, excellent pH stability and great rejection of all pharmaceuticals investigated (>94%). For commercial CTA based FO membranes, hydrophobic interaction between the compounds and membranes exhibited strong influence on their rejection under acidic conditions. The pharmaceuticals rejection was well correlated to their hydrophobicity (log D). Under alkaline conditions, both electrostatic repulsion and size exclusion contributed to the removal of deprotonated molecules. The pharmaceuticals rejection by CTA-HW membrane at pH 8 followed the order: diclofenac (99%)>carbamazepine (95%)>ibuprofen (93%) ≈ naproxen (93%). These results can be important for FO membrane synthesis, modification and their application in water purification. PMID:22640821

  2. Bromination of selected pharmaceuticals in water matrices.

    PubMed

    Benitez, F Javier; Acero, Juan L; Real, Francisco J; Roldan, Gloria; Casas, Francisco

    2011-11-01

    The bromination of five selected pharmaceuticals (metoprolol, naproxen, amoxicillin, phenacetin, and hydrochlorothiazide) was studied with these compounds individually dissolved in ultra-pure water. The apparent rate constants for the bromination reaction were determined as a function of the pH, obtaining the sequence amoxicillin>naproxen>hydrochlorothiazide≈phenacetin≈metoprolol. A kinetic mechanism specifying the dissociation reactions and the species formed for each compound according to its pK(a) value and the pH allowed the intrinsic rate constants to be determined for each elementary reaction. There was fairly good agreement between the experimental and calculated values of the apparent rate constants, confirming the goodness of the proposed reaction mechanism. In a second stage, the bromination of the selected pharmaceuticals simultaneously dissolved in three water matrices (a groundwater, a surface water from a public reservoir, and a secondary effluent from a WWTP) was investigated. The pharmaceutical elimination trend agreed with the previously determined rate constants. The influence of the main operating conditions (pH, initial bromine dose, and characteristics of the water matrix) on the degradation of the pharmaceuticals was established. An elimination concentration profile for each pharmaceutical in the water matrices was proposed based on the use of the previously evaluated apparent rate constants, and the theoretical results agreed satisfactorily with experiment. Finally, chlorination experiments performed in the presence of bromide showed that low bromide concentrations slightly accelerate the oxidation of the selected pharmaceuticals during chlorine disinfection. PMID:21906777

  3. Drug approval and surveillance.

    PubMed

    Potts, M

    1980-01-01

    This article argues that current regulations governing the licensing of drugs, particularly in the U.S., need to be changed and replaced by a system of provisional or conditional licensing and increased postmarketing surveillance of drug use. In terms of research and development of new forms of contraception, this proposal would have great impact. It is believed that the U.S./Food and Drug Administration (FDA) requirements--animal experiments and Phase 1 and 2 clinical trials--not only put an unacceptable financial burden on any institution attempting to develop new contraceptives, but do not demonstrably contribute to the reduction of risks. The author questions whether even if oral contraceptives introduced prior to new U.S./FDA regulations had been subject to these current regulations that convincing evidence would have been found to alert anyone to the now-known rare adverse effects, such as risk of thromboembolism. It is pointed out that these sorts of rare risks were uncovered by continuous screening processes which are not now a part of the FDA drug regulation requirements. The author also questions the politics of "conpulsory safety," such as might be legislated for regulated car safety belt use. Citing a partnership already established between government and private industry in high-risk/low cost ventures in the aerospace industry, the author sees no reason why such a relationship could not evolve in the pharmaceutical industry. In Britain, proposals have been made to establish a fund to compensate patients adversely affected by drugs which pharmaceutical companies would reimburse if proved negligent; such a fund may work in the U.S. under new regulations which stress postmarketing surveillance. PMID:6110574

  4. Recent advances in capillary electrophoretic migration techniques for pharmaceutical analysis (2013-2015).

    PubMed

    El Deeb, Sami; Wätzig, Hermann; Abd El-Hady, Deia; Sänger-van de Griend, Cari; Scriba, Gerhard K E

    2016-07-01

    This review updates and follows-up a previous review by highlighting recent advancements regarding capillary electromigration methodologies and applications in pharmaceutical analysis. General approaches such as quality by design as well as sample injection methods and detection sensitivity are discussed. The separation and analysis of drug-related substances, chiral CE, and chiral CE-MS in addition to the determination of physicochemical constants are addressed. The advantages of applying affinity capillary electrophoresis in studying receptor-ligand interactions are highlighted. Finally, current aspects related to the analysis of biopharmaceuticals are reviewed. The present review covers the literature between January 2013 and December 2015. PMID:26988029

  5. [Response of Pharmaceutical Companies to the Crisis of Post-Marketing Clinical Trials of Anti-Cancer Agents -- Results of Questionnaires to Pharmaceutical Companies].

    PubMed

    Nakajima, Toshifusa

    2016-04-01

    Investigator-oriented post-marketing clinical trials of anti-cancer agents are faced to financial crisis due to drastic decrease in research-funds from pharmaceutical companies caused by a scandal in 2013. In order to assess the balance of research funds between 2012 and 2014, we made queries to 26 companies manufacturing anti-cancer agents, and only 10 of 26 responded to our queries. Decrease in the fund was observed in 5 of 10, no change in 1, increase in 3 and no answer in 1. Companies showed passive attitude to carry out doctor-oriented clinical trials of off-patent drugs or unapproved drugs according to advanced medical care B program, though some companies answered to proceed approved routines of these drugs if clinical trials showed good results. Most companies declined to make comments on the activity of Japan Agency for Medical Research and Development (AMED), but some insisted to produce good corroboration between AMED and pharmaceutical companies in order to improve the quality of trials. Further corroboration must be necessary for this purpose among researchers, governmental administrative organs, pharmaceutical companies, patients' groups, and mass-media. PMID:27220801

  6. The shaping of pharmaceutical governance: the Israeli case

    PubMed Central

    2014-01-01

    This article focuses on governance of the pharmaceutical sector in Israel. It traces the relationships between the state, industry, and sick funds from before the establishment of National Health Insurance (NHI) in 1995 to the beginning of this decade, in particular as they have grappled with the challenge of making national formulary decisions in a rational manner. Subsequent to the introduction of NHI there have been shifts in the modes and mix of governance. This research shows empirically that a relatively complex mix of hierarchical and network modes of governance can be successfully established over an extended period of time when flexibility is maintained through the implementation process. The system for defining and updating a standard basket of health services has coped well with the challenge of managing a range of difficult and potentially volatile stakeholder relationships in the pharmaceutical sector and of distancing ministers from controversies of funding and listing decisions. Government has succeeded in containing drug costs whilst still maintaining a basket of reimbursable drugs that, from an international perspective, is comprehensive and technologically advanced. On the other hand, network arrangements appear to have delayed the introduction of suitable accountability relationships and hindered their development. The state has traditionally played an intermediary role between unavoidable corporate interests of industry and sick funds, with little transparency and to the detriment of more pluralistic access to decision making. Governance arrangements in Israel appear to limit the potential and incentive of the state and the sick funds to realize their potential countervailing powers in subsidy and pricing decisions. PMID:24914409

  7. The shaping of pharmaceutical governance: the Israeli case.

    PubMed

    Sax, Philip

    2014-01-01

    This article focuses on governance of the pharmaceutical sector in Israel. It traces the relationships between the state, industry, and sick funds from before the establishment of National Health Insurance (NHI) in 1995 to the beginning of this decade, in particular as they have grappled with the challenge of making national formulary decisions in a rational manner. Subsequent to the introduction of NHI there have been shifts in the modes and mix of governance. This research shows empirically that a relatively complex mix of hierarchical and network modes of governance can be successfully established over an extended period of time when flexibility is maintained through the implementation process. The system for defining and updating a standard basket of health services has coped well with the challenge of managing a range of difficult and potentially volatile stakeholder relationships in the pharmaceutical sector and of distancing ministers from controversies of funding and listing decisions. Government has succeeded in containing drug costs whilst still maintaining a basket of reimbursable drugs that, from an international perspective, is comprehensive and technologically advanced. On the other hand, network arrangements appear to have delayed the introduction of suitable accountability relationships and hindered their development. The state has traditionally played an intermediary role between unavoidable corporate interests of industry and sick funds, with little transparency and to the detriment of more pluralistic access to decision making. Governance arrangements in Israel appear to limit the potential and incentive of the state and the sick funds to realize their potential countervailing powers in subsidy and pricing decisions. PMID:24914409

  8. 76 FR 2263 - Approval and Promulgation of Air Quality Implementation Plans; Minnesota; Gopher Resource, LLC

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-13

    ... update, which EPA approved on June 3, 2008 (73 FR 31614). On November 16, 2010, the Administrator of EPA... 3 . A subsequent Federal Register notice published on November 22, 2010 (75 FR 71033), confirmed... Secondary Lead Smelting (62 FR 32209). The amendments affirm that if a compliance test shows a...

  9. 75 FR 4066 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-26

    ... and approval according to the procedures prescribed in 5 CFR 1320.12. On October 23, 2009 (74 FR 54801... enhanced and expanded data to update performance management dashboards that summarize and synthesize... key program areas. The dashboards include measures of progress, information about resources...

  10. 77 FR 18 - General Working Conditions in Shipyard Employment; Approval of Information Collection Requirements

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-03

    ... final rule, published May 2, 2011 (76 FR 24576), became effective and enforceable on August 1, 2011... Employment on May 2, 2011 (76 FR 24576), updating existing requirements to reflect advances in industry... Federal Register announcing that OMB approved and assigned a control number to the requirements. See 76...

  11. 76 FR 55667 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-08

    ... and approval according to the procedures prescribed in 5 CFR 1320.12. On December 29, 2010 (75 FR... compliance with the PCB regulations. The information collected by these requirements will update the Agency's knowledge of ongoing PCB activities, ensure that individuals using or disposing of PCBs are held...

  12. 78 FR 68136 - Agency Information Collection Activities; Revision of an Approved Information Collection...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-13

    ... on January 17, 2008 (73 FR 3316), or you may visit http://edocket.access.gpo.gov/2008/pdfE8-794.pdf... Motor Vehicles'' (75 FR 72987), November 29, 2010, providing additional consumer protection... update other wage related costs that have changed since the last approval. This ICR is necessary...

  13. 75 FR 27938 - Approval and Promulgation of Implementation Plans; State of California; Legal Authority

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-19

    ... ``Chapter 3--Legal Authority'' as an update and clarification of the 1972 SIP. See 44 FR 38912 (July 3, 1979.... Final Action IV. Statutory and Executive Order Reviews I. Proposed Action On January 29, 2010 (75 FR... California SIP. See 37 FR 10842 (May 31, 1972) and 40 CFR 52.220(b). EPA's approval included both chapter...

  14. 78 FR 28776 - Approval and Promulgation of Implementation Plans; Georgia; State Implementation Plan...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-16

    ... AGENCY 40 CFR Part 52 Approval and Promulgation of Implementation Plans; Georgia; State Implementation.... SUMMARY: EPA is proposing changes to the Georgia State Implementation Plan (SIP) submitted by the Georgia..., the SIP revisions update the Georgia SIP to reflect EPA's current national ambient air...

  15. 28 CFR 58.21 - Minimum requirements to become and remain approved agencies relating to fees.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... income is less than 150 percent of the poverty guidelines updated periodically in the Federal Register by... the United States Trustee to charge such a fee; (2) A fee exceeding $50 for credit counseling services is not presumed to be reasonable and an agency must obtain prior approval from the United...

  16. 28 CFR 58.21 - Minimum requirements to become and remain approved agencies relating to fees.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... income is less than 150 percent of the poverty guidelines updated periodically in the Federal Register by... the United States Trustee to charge such a fee; (2) A fee exceeding $50 for credit counseling services is not presumed to be reasonable and an agency must obtain prior approval from the United...

  17. 77 FR 38557 - Approval and Promulgation of Implementation Plans; Revisions to the Nevada State Implementation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-28

    ... to provide the public with notice through ``prominent advertisement'' in the area affected. \\8\\ NDEP... Nevada SIP? On April 17, 2007 (72 FR 19144), we proposed to disapprove a previous version of essentially... taken a number of actions to approve (or in a few cases, disapprove) these SIP updates. See, e.g., 71...

  18. 78 FR 57213 - Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-17

    ... construction. Electrical vault. Taxiway H construction. Storm water update. Gulfstream Road/tunnel design..., (601) 664-9893. Public Agency: Niagara Frontier Transportation Authority, Buffalo, New York... Description of Projects Approved for Collection and Use at Buffalo Niagara International Airport (BUF) at a...

  19. 77 FR 56241 - Notice of Withdrawal of Final Design Approval; Westinghouse Electric Company; Advanced Passive 1000

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-12

    ... COMMISSION Notice of Withdrawal of Final Design Approval; Westinghouse Electric Company; Advanced Passive 1000 By letter dated December 10, 2010, Westinghouse Electric Company (WEC) requested that the U.S... initial certification of the four current DCRs was to request that the FDA holder update the Final...

  20. 78 FR 19596 - Approval and Promulgation of Air Quality Implementation Plans; Arkansas; Prevention of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-02

    ...The EPA is taking final action to approve two revisions to the Arkansas State Implementation Plan (SIP) submitted by the Arkansas Department of Environmental Quality (ADEQ) to EPA on February 17, 2010, and November 6, 2012. The February 17, 2010, SIP revision to the Arkansas New Source Review (NSR) Prevention of Significant Deterioration (PSD) program updates the Arkansas SIP to incorporate by......

  1. 78 FR 2354 - Approval and Promulgation of Air Quality Implementation Plans; Arkansas; Prevention of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-11

    ...The EPA is proposing to approve two revisions to the Arkansas State Implementation Plan (SIP) submitted by the Arkansas Department of Environmental Quality (ADEQ) to EPA on February 17, 2010 and November 6, 2012. The February 17, 2010 proposed SIP revision to the Arkansas New Source Review (NSR) Prevention of Significant Deterioration (PSD) program updates the Arkansas SIP to incorporate by......

  2. 78 FR 67327 - Approval and Promulgation of Air Quality Implementation Plans; State of Colorado; Revised...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-12

    ...EPA is proposing approval of a State Implementation Plan (SIP) revision submitted by the State of Colorado on May 11, 2012. The May 11, 2012 submittal addresses updates to Regulation Number 10 ``Criteria for Analysis of Conformity'' of the Colorado SIP including revisions to transportation conformity requirements, transportation conformity criteria and procedures related to interagency......

  3. 76 FR 74841 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-01

    ... Reduction Act of 1995, FAA invites public comments about our ] intention to request the Office of Management... 8050-1, (approved under OMB control number 2120- 0042). The updated registration database will then be... information collection to the Office of Information and Regulatory Affairs, Office of Management and...

  4. 76 FR 17599 - Approval and Promulgation of Implementation Plans; State of Kansas

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-30

    ... NAAQS. (62 FR 38894; 62 FR 38711). On January 8, 2008, EPA Region 7 received the state of Kansas' ozone... rulemaking (72 FR 10608).\\5\\ \\5\\ Subsequent to this approval, updated modeling in support of the proposed Transport Rule (75 FR 45210) has indicated that emissions from Kansas interfere with maintenance of the...

  5. 78 FR 78310 - Approval and Promulgation of Implementation Plans; North Carolina; Transportation Conformity...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-26

    ... Conformity Memorandum of Agreement Update AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: The Environmental Protection Agency (EPA) is proposing to approve a revision to the... Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta,...

  6. 77 FR 74355 - Approval of Air Quality Implementation Plans; California; San Joaquin Valley; Attainment Plan for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-14

    ... AGENCY 40 CFR Part 52 Approval of Air Quality Implementation Plans; California; San Joaquin Valley... Quality Standards in the San Joaquin Valley. This technical amendment corrects the CFR to properly codify the California Air Resources Board's commitment to update the air quality modeling in the San...

  7. Water and stability of pharmaceutical solids

    NASA Astrophysics Data System (ADS)

    Shalaev, Evgenyi

    2007-03-01

    Solid pharmaceuticals are multi-component systems consisting of an active pharmaceutical ingredient (API) and inactive ingredients (excipients). Excipients may include inorganic salts (e.g., NaCl), carbohydrates (e.g., lactose), and polymers, to name a few, whereas APIs range from relatively simple molecules (e.g., aspirin) to proteins and olygonucleotides. Pharmaceutical solids could exist either as single-phase or heterophase systems. They also may have different extent of order, such as highly ordered crystalline phases, amorphous solids that are thermodynamically unstable but might be kinetically stable under the time frame of observation, and crystalline mesophases including liquid crystals. With all this diversity, there are common features for such systems, and two of them will be discussed in the presentation. (i) Requirements for chemical stability of pharmaceuticals are very strict. A very limited (e.g., less than 0.1%) extent of conversion is allowed in these materials over the shelf life, i.e., during several years of storage at ambient and (sometimes) not fully controlled (e.g., a medicine cabinet in one's bathroom) conditions. (ii) All pharmaceutical solids contain some water, although its amount and physical state are highly variable and may change during manufacturing and shelf life. There are many challenging questions and issues associated with the ``Water and stability of pharmaceutical solids'' subject; some of them will be considered in the presentation: (i) What are the features of chemical reactivity of crystalline vs disordered systems? (ii) What is the role of water in solid state chemical reactivity of amorphous solids, e.g., water as plasticizer vs reactant vs reaction media? (iii) How homogeneous are pharmaceutical amorphous solid solutions, e.g., carbohydrate-water systems? (iv) What is the optimal water content? With water being the most common destabilizing factor, is ``the drier - the better'' always the case?

  8. AN INFORMATIC APPROACH TO ESTIMATING ECOLOGICAL RISKS POSED BY PHARMACEUTICAL USE: HUMAN PRESCRIPTION PHARMACEUTICALS

    EPA Science Inventory

    Pharmaceuticals are often excreted from patients as the parent compound or as active metabolites. Some of these compounds have been found in the environment. However, the environmental concentrations of the majority of pharmaceuticals and their metabolites are not known. The re...

  9. Determination of elemental impurities in pharmaceutical products and related matrices by ICP-based methods: a review.

    PubMed

    Barin, Juliano S; Mello, Paola A; Mesko, Marcia F; Duarte, Fabio A; Flores, Erico M M

    2016-07-01

    Interest in the determination of elemental impurities in pharmaceuticals has increased in recent years because of changes in regulatory requirements and the need for changing or updating the current limit tests recommended in pharmacopeias. Inductively coupled plasma (ICP) optical emission spectrometry and ICP mass spectrometry are suitable alternatives to perform multielemental analysis for this purpose. The main advantages and limitations of these techniques are described, covering the applications reported in the literature in the last 10 years mainly for active pharmaceutical ingredients, raw materials, and pharmaceutical dosage forms. Strategies used for sample preparation, including dissolution in aqueous or organic solvents, extraction, wet digestion and combustion methods are described, as well as direct solid analysis and ICP-based systems applied for speciation analysis. Interferences observed during the analysis of pharmaceutical products using ICP-based methods are discussed. Methods currently recommended by pharmacopeias for elemental impurities are also covered, showing that the use of ICP-based methods could be considered as a trend in the determination of these impurities in pharmaceuticals. However, the development of a general method that is accurate for all elemental impurities and the establishment of an official method are still challenges. In this regard, the main drawbacks and suitable alternatives are discussed. PMID:27020927

  10. Lesinurad: First Global Approval.

    PubMed

    Hoy, Sheridan M

    2016-03-01

    Lesinurad (ZURAMPIC(®)) is an oral urate-anion exchanger transporter 1 (URAT1) inhibitor developed by Ardea Biosciences (a subsidiary of AstraZeneca) for the treatment of hyperuricaemia associated with gout. It reduces serum uric acid (sUA) levels by inhibiting the function of the transporter proteins (URAT1 and organic anion transporter 4) involved in uric acid reabsorption in the kidney. In December 2015, lesinurad was approved in the USA as combination therapy with a xanthine oxidase inhibitor for the treatment of hyperuricaemia associated with gout in patients who have not achieved sUA target levels with a xanthine oxidase inhibitor alone. Lesinurad has also received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for this indication and is in phase III development as a combination therapy in several other countries. This article summarizes the milestones in the development of lesinurad leading to this first approval for hyperuricaemia associated with gout. PMID:26861027

  11. Necitumumab: First Global Approval.

    PubMed

    Garnock-Jones, Karly P

    2016-02-01

    Eli Lilly is developing necitumumab (Portrazza™), an intravenously administered fully human IgG monoclonal antibody directed against the epidermal growth factor receptor (EGFR), which is expressed in a variety of solid tumours and has been implicated in promoting oncogenesis and tumour progression. Necitumumab is approved as a part of combination therapy (with gemcitabine and cisplatin) in the USA for the first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC), and regulatory submissions have been made in the EU for this same indication. Necitumumab was derived from the proprietary phage display library of Dyax Corp, and originated with ImClone Systems, which was acquired by Eli Lilly in November 2008. Necitumumab was also under phase II development for colorectal cancer in Belgium and Spain; however, no recent development has been reported for this indication. This article summarizes the milestones in the development of necitumumab leading to this first approval for the first-line treatment of metastatic squamous NSCLC, in combination with gemcitabine and cisplatin. PMID:26729188

  12. Dinutuximab: first global approval.

    PubMed

    Dhillon, Sohita

    2015-05-01

    United Therapeutics Corporation and the National Cancer Institute are developing dinutuximab (Unituxin™; ch14.18), a monoclonal antibody targeting GD2, for the treatment of neuroblastoma. GD2 is a glycolipid found on the surface of tumour cells, which is overexpressed in neuroblastoma. Dinutuximab, an IgG1 human/mouse chimeric switch variant of murine monoclonal antibody 14G2a, binds to GD2 and induces antibody-dependent cell-mediated cytotoxicity and complement-dependent cytotoxicity. The US FDA has recently approved the use of dinutuximab combination therapy for the treatment of high-risk neuroblastoma in paediatric patients. The marketing authorization application for dinutuximab is under regulatory review in the EU, and phase I-III development is underway in several other countries. This article summarizes the milestones in the development of dinutuximab leading to this first approval for use (in combination with granulocyte macrophage colony-stimulating factor, interleukin-2 and 13-cis retinoic acid) in the treatment of paediatric patients with high-risk neuroblastoma who achieve at least partial response to prior first-line multiagent, multimodality therapy. PMID:25940913

  13. Sonidegib: First Global Approval.

    PubMed

    Burness, Celeste B

    2015-09-01

    Sonidegib (Odomzo™) is an orally bioavailable, small molecule, Smoothened (SMO) receptor antagonist that is being developed by Novartis for the treatment of cancer. SMO is a G protein-coupled receptor-like molecule that is essential for the actions of the Hedgehog family of secreted proteins, which play a critical role in the development and homeostasis of many organs and tissues. Oral sonidegib is approved in Switzerland for the treatment of adult patients with advanced basal cell carcinoma (BCC) and in the US and EU for the treatment of adult patients with locally advanced BCC that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. Submissions to other global authorities are being contemplated or planned. Additionally, phase I/II investigation is being conducted in other malignancies, including multiple myeloma, medulloblastoma, myelofibrosis, ovarian cancer, prostate cancer, breast cancer, chronic myeloid leukaemia, myelodysplastic syndromes, oesophageal cancer and pancreatic cancer. This article summarizes the milestones in the development of sonidegib leading to the first approvals for advanced and locally advanced BCC. PMID:26323341

  14. [Discussion about traditional Chinese medicine pharmacokinetics study based on first botanical drug approved by FDA].

    PubMed

    Huang, Fanghua

    2010-04-01

    Pharmacokinetics study is one of main components of pharmaceuticals development. Food and Drug Administration (FDA) approved Veregen as the first botanical drug in 2006. This article introduced FDA's requirement on pharmacokinetics study of botanical drug and pharmacokinetics studies of Veregen, summarized current requirement and status quo of pharmacokinetics study on traditional Chinese medicine (TCM) and natural medicine in China, and discussed about pharmacokinetics study strategy for TCM and natural medicine. PMID:20575403

  15. A perspective on the benefit-risk assessment for new and emerging pharmaceuticals in Japan

    PubMed Central

    Tanimoto, Tetsuya

    2015-01-01

    The universal health care system in Japan is facing a historical turning point as a result of the increasing fiscal burden, rapidly aging society, and a decreasing population. To understand the challenges and opportunities in the Japanese pharmaceutical market, which occupies one tenth of the global share, this review highlights several issues related to the benefit-risk assessment that is unique to the modern Japanese society: 1) regulatory system for new drug development; 2) health hazards related to pharmaceuticals (“Yakugai” in Japanese); 3) drug lag; 4) problems and controversies in the vaccination policy; and 5) clinical study misconduct. The regulatory process places a significant importance on Japanese data collection regardless of data accumulation from other countries. Because Yakugai has repeatedly caused tragedies and social disputes historically, the regulatory judgments generally tend to be more prudential when safety concerns are raised for new and emerging pharmaceuticals. Such a regulatory system has caused more than several years of approval delays compared to delays in other countries. The problem of drug lag still lingers on despite several regulatory system revisions, while the solution is incompatible with the elimination of Yakugai because the lag potentially reduces the risk of unpredictable adverse events. The Japanese vaccination policy has also received a lot of criticism, and needs improvements so that the decision-making process can be more transparent and scientifically based. Additionally, repeated clinical study misconduct damaged the reputation of Japanese clinical studies with unnecessary defrayment in health insurance; therefore, the medical community must change its inappropriate relationship with the industry. The problems surrounding pharmaceuticals are related to centralized, strict drug pricing control under the universal health coverage. Although the current government attempts to facilitate innovative research and

  16. Changing R&D models in research-based pharmaceutical companies.

    PubMed

    Schuhmacher, Alexander; Gassmann, Oliver; Hinder, Markus

    2016-01-01

    New drugs serving unmet medical needs are one of the key value drivers of research-based pharmaceutical companies. The efficiency of research and development (R&D), defined as the successful approval and launch of new medicines (output) in the rate of the monetary investments required for R&D (input), has declined since decades. We aimed to identify, analyze and describe the factors that impact the R&D efficiency. Based on publicly available information, we reviewed the R&D models of major research-based pharmaceutical companies and analyzed the key challenges and success factors of a sustainable R&D output. We calculated that the R&D efficiencies of major research-based pharmaceutical companies were in the range of USD 3.2-32.3 billion (2006-2014). As these numbers challenge the model of an innovation-driven pharmaceutical industry, we analyzed the concepts that companies are following to increase their R&D efficiencies: (A) Activities to reduce portfolio and project risk, (B) activities to reduce R&D costs, and (C) activities to increase the innovation potential. While category A comprises measures such as portfolio management and licensing, measures grouped in category B are outsourcing and risk-sharing in late-stage development. Companies made diverse steps to increase their innovation potential and open innovation, exemplified by open source, innovation centers, or crowdsourcing, plays a key role in doing so. In conclusion, research-based pharmaceutical companies need to be aware of the key factors, which impact the rate of innovation, R&D cost and probability of success. Depending on their company strategy and their R&D set-up they can opt for one of the following open innovators: knowledge creator, knowledge integrator or knowledge leverager. PMID:27118048

  17. Pharmaceutical supply chain risks: a systematic review

    PubMed Central

    2013-01-01

    Introduction Supply of medicine as a strategic product in any health system is a top priority. Pharmaceutical companies, a major player of the drug supply chain, are subject to many risks. These risks disrupt the supply of medicine in many ways such as their quantity and quality and their delivery to the right place and customers and at the right time. Therefore risk identification in the supply process of pharmaceutical companies and mitigate them is highly recommended. Objective In this study it is attempted to investigate pharmaceutical supply chain risks with perspective of manufacturing companies. Methods Scopus, PubMed, Web of Science bibliographic databases and Google scholar scientific search engines were searched for pharmaceutical supply chain risk management studies with 6 different groups of keywords. All results found by keywords were reviewed and none-relevant articles were excluded by outcome of interests and researcher boundaries of study within 4 steps and through a systematic method. Results Nine articles were included in the systematic review and totally 50 main risks based on study outcome of interest extracted which classified in 7 categories. Most of reported risks were related to supply and supplier issues. Organization and strategy issues, financial, logistic, political, market and regulatory issues were in next level of importance. Conclusion It was shown that the majority of risks in pharmaceutical supply chain were internal risks due to processes, people and functions mismanagement which could be managed by suitable mitigation strategies. PMID:24355166

  18. [Pharmaceutical applications of sulfobuthylether-beta-cyclodextrin].

    PubMed

    Sebestyén, Zita; Szepesi, Katalin; Szabó, Barnabás

    2013-01-01

    Sulfobuthylether-beta-cyclodextrin (SBECD) is a substituted derivative of a cyclic oligosaccharide containing seven glucopyranose units, which bear pH-independent negative charges because of sulfonate groups. This derivative has better solubility and toxicological characteristics than the unsubstituted beta-cyclodextrin, and the presence of sulfobuthyl groups opens new dimensions in the interactions acting the part of the complex formation. These create opportunities for the pharmaceutical applications of this compound. Currently six pharmaceutical preparations circulate--moiety of these circulates in Hungary also--which have a composition containing SBECD as pharmaceutical excipient. Out of the main effects of the complex-forming agent the solubility enhancement is utilized in these compositions to achieve the solution of a therapeutic dose in the case of intravascular administration. Available experimental evidences and published patents are indicative of broadening the circle of the applications in point of both technological advantages and dosage forms. PMID:23926650

  19. Pharmaceutical strategy and innovation: an academics perspective.

    PubMed

    Baxendale, Ian R; Hayward, John J; Ley, Steven V; Tranmer, Geoffrey K

    2007-06-01

    The pharmaceutical industry is under increasing pressure on many fronts, from investors requiring larger returns to consumer groups and health authorities demanding cheaper and safer drugs. It is also feeling additional pressure from the infringement upon its profit margins by generic drug producers. Many companies are aggressively pursuing outsourcing contracts in an attempt to counter many of the financial pressures and streamline their operations. At the same time, the productivity of the pharmaceutical industry at its science base is being questioned in terms of the number of products and the timeframes required for each company to deliver them to market. This has generated uncertainties regarding the current corporate strategies that have been adopted and the levels of innovation being demonstrated. In this essay we discuss these topics in the context of the global pharmaceutical market, investigating the basis for many of these issues and highlighting the hurdles the industry needs to overcome, especially as they relate to the chemical sciences. PMID:17458911

  20. The economics of pharmaceutical supply in Tanzania.

    PubMed

    Yudkin, J S

    1980-01-01

    This paper analyzes the patterns of purchasing, distribution, and utilization of pharmaceuticals currently found in Tanzania, an underdeveloped country in Africa. Like other nations in the Third World, Tanzania offers the prospect of a rapidly expanding market for the multinational pharmaceutical industry. However, this market has been to a large extent developed by the intense promotional activities of the drug companies themselves. In addition to normal marketing methods, these companies indulge in techniques which would be neither acceptable nor legal in developed countries. As a result, expensive proprietary drugs are overpurchased and overprescribed, mainly in the large urban hospitals, with consequent deprivation of other health care facilities, particularly those for the rural peasants who form the majority of the population. The activities of the multinational pharmaceutical companies in the Third World are therefore an important component in the continuing underdevelopment of health in these nations. PMID:7419314

  1. Thermal properties of food and pharmaceutical powders

    NASA Astrophysics Data System (ADS)

    Abiad, Mohamad Ghassan

    Foods and pharmaceuticals are complex systems usually exposed to various environmental conditions during processing and thus storage, stability, functionality and quality are key attributes that deserve careful attention. The quality and stability of foods and pharmaceuticals are mainly affected by environmental conditions such as temperature, humidity, time, and processing conditions (e.g. shear, pressure) under which they may undergo physical and/or chemical transformations. Glass transition as well as other thermal properties is a key to understand how external conditions affect physical changes of such materials. Development of new materials and understanding the physico-chemical behavior of existing ones require a scientific foundation that translates into safe and high quality foods, improved quality of pharmaceuticals and nutraceuticals with lower risk to patients and functional efficacy of polymers used in food and medicinal products. This research provides an overview of the glass transition and other thermal properties and introduces novel methods developed to characterize such properties.

  2. WHO Expert Committee on specifications for pharmaceutical preparations.

    PubMed

    2010-01-01

    The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: good practices for pharmaceutical quality control laboratories; supplementary guidelines for active pharmaceutical ingredients; good manufacturing practices for pharmaceutical products containing hazardous substances; good manufacturing practices for sterile pharmaceutical products; good distribution practices for pharmaceutical products; guidelines on the requalification of prequalified dossiers: and guidelines for the preparation of a contract research organization master file. PMID:20560300

  3. Sulfite-containing Canadian pharmaceutical products available in 1991.

    PubMed Central

    Miyata, M; Schuster, B; Schellenberg, R

    1992-01-01

    OBJECTIVE: To compile an inclusive list of Canadian pharmaceutical products available in 1991 that contained sulfites. DATA SOURCES: Written and oral responses from 94 pharmaceutical companies selected from the 1989 Compendium of Pharmaceuticals and Specialties. RESULTS: A list of sulfite-containing pharmaceutical products was compiled from data supplied by the 90 responding companies. Companies whose products contained no sulfites were separately identified. CONCLUSIONS: Sulfites are present in many pharmaceutical products and are one of many excipients and additives that have been reported to cause severe adverse reactions. The provided list should be a useful aid for health care practitioners when prescribing pharmaceutical products for sulfite-sensitive patients. PMID:1483237

  4. Terahertz study on porosity and mass fraction of active pharmaceutical ingredient of pharmaceutical tablets.

    PubMed

    Bawuah, Prince; Tan, Nicholas; Tweneboah, Samuel Nana A; Ervasti, Tuomas; Axel Zeitler, J; Ketolainen, Jarkko; Peiponen, Kai-Erik

    2016-08-01

    In this study, terahertz time-domain spectroscopic (THz-TDS) technique has been used to ascertain the change in the optical properties, as a function of changing porosity and mass fraction of active pharmaceutical ingredient (API), of training sets of pharmaceutical tablets. Four training sets of pharmaceutical tablets were compressed with microcrystalline cellulose (MCC) excipient and indomethacin API by varying either the porosity, height, and API mass fraction or all three tablet parameters. It was observed, as far as we know, for the first time, that the THz time-domain and frequency-domain effective refractive index, as well as, the frequency-domain effective absorption coefficient both show linear correlations with the porosity and API mass fraction for training sets of real pharmaceutical tablets. We suggest that, the observed linear correlations can be useful in basic research and quality inspection of pharmaceutical tablets. Additionally, we propose a novel optical strain parameter, based on THz measurement, which yields information on the conventional strain parameter of a tablet as well as on the change of fill fraction of solid material during compression of porous pharmaceutical tablets. We suggest that the THz measurement and proposed method of data analysis, in addition to providing an efficient tool for basic research of porous media, can serve as one of the novel quality by design (QbD) implementation techniques to predict critical quality attributes (CQA) such as porosity, API mass fraction and strain of flat-faced pharmaceutical tablets before production. PMID:27288937

  5. Pharmaceutical patent law: the Canadian perspective.

    PubMed

    Aumand, Livia; Norman, John

    2016-07-01

    This article provides an overview of the patent regime in Canada, with a focus on issues most relevant to the pharmaceutical industry. The process of applying for a patent is discussed, as well as enforcement and litigation. Recent developments in the case law dealing with patentability requirements - novelty, obviousness, utility and sufficiency - are reviewed. Finally, the impact of recently negotiated trade agreements on Canadian patent law is addressed. In this article, we aim to provide an overview of the patent regime in Canada, with a focus on issues that are particularly relevant to the pharmaceutical industry. PMID:27346187

  6. Pharmaceutical regulation in the single European market.

    PubMed

    Matthews, D; Wilson, C

    1998-01-01

    This paper assesses the impact of new EU-wide drug authorisation procedures. The paper examines various attempts to introduce harmonised market authorisation routes for pharmaceuticals including the establishment of the multi-state, concentration, decentralised and centralised procedures. The paper considers the current role of the European Medicines Evaluation Agency and the likelihood that its powers will be increased in the future. Finally, the paper assesses whether EU regulation has created beneficial market conditions for pharmaceutical companies operating in the single European market. PMID:9922630

  7. [Major milestones for European pharmaceutical policy].

    PubMed

    Sauer, Fernand

    2014-01-01

    Under the 1985 White Paper on the completion of the single market, several pharmaceutical harmonisation measures were unanimously adopted, in favor of biotech products and on pricing transparency, legal status of prescription, wholesale distribution and advertising. The European pharmaceutical harmonisation was extended to Norway and Iceland, to new accession member states and through major international conferences with the US and Japan (ICH). Starting in 1995, the European medicines agency has produced an efficient marketing authorisation system for new human and veterinary medicines. The system was extended to pediatric medicines and advanced therapies. The monitoring of drug adverse effects (pharmacovigilance) has been gradually strengthened. PMID:25668913

  8. The view of the pharmaceutical industry.

    PubMed

    Roche, G; Helenport, J P

    1994-06-01

    Rhône-Poulenc Rorer has committed itself to the development of artemether because we believe the drug will be of considerable benefit to sufferers from severe falciparum malaria, and because it is a stable, effective and economical compound that can be given by intramuscular injection. The quality of the pharmaceutical product meets international regulatory standards. Artemether is unlikely to yield big profits, but we believe that major pharmaceutical companies have a responsibility to develop such much-needed products. To develop this project further, we will need the assistance of academic institutions, research organizations and international bodies. PMID:8053031

  9. Update on osteoporosis management in long-term care: focus on bisphosphonates.

    PubMed

    Kamel, Hosam K

    2007-09-01

    Osteoporotic fractures are potentially devastating and associated with high morbidity and substantial economic burden. Residents of long-term care facilities are at greater risk of osteoporosis and its related fractures than those living in the community, yet osteoporosis is underdiagnosed and undertreated in these settings. Bisphosphonates are approved by the Food and Drug Administration for the treatment and prevention of osteoporosis in postmenopausal women. As a class, bisphosphonates have been shown to increase bone mineral density, decrease the markers of bone resorption, and reduce the risk of osteoporotic fractures. The 3 approved bisphosphonates are alendronate, risedronate, and ibandronate. Alendronate and risedronate are dosed daily or weekly and ibandronate, the most recently approved bisphosphonate, has been approved for monthly oral dosing or as an intravenous formulation to be given intermittently (every 3 months). In addition, other products with different mechanisms of action are in the pharmaceutical pipeline and may offer additional management options. PMID:17845945

  10. Updating Older Fume Hoods.

    ERIC Educational Resources Information Center

    Saunders, G. Thomas

    1985-01-01

    Provides information on updating older fume hoods. Areas addressed include: (1) adjustment of the hood's back baffle; (2) hood air leakage; (3) light level; (4) hood location in relation to room traffic and room air; and (5) establishing and maintaining hood performance. (JN)

  11. Update: Biological Nitrogen Fixation.

    ERIC Educational Resources Information Center

    Wiseman, Alan; And Others

    1985-01-01

    Updates knowledge on nitrogen fixation, indicating that investigation of free-living nitrogen-fixing organisms is proving useful in understanding bacterial partners and is expected to lead to development of more effective symbioses. Specific areas considered include biochemistry/genetics, synthesis control, proteins and enzymes, symbiotic systems,…

  12. Veterinary medicines update.

    PubMed

    2016-03-01

    The following information has been produced for Veterinary Record by the Veterinary Medicines Directorate (VMD) to provide an update for veterinary surgeons on recent changes to marketing authorisations for veterinary medicines in the UK and on other relevant issues. PMID:26940413

  13. Veterinary medicines update.

    PubMed

    2016-02-01

    The following information has been produced for Veterinary Record by the Veterinary Medicines Directorate (VMD) to provide an update for veterinary surgeons on recent changes to marketing authorisations for veterinary medicines in the UK and on other relevant issues. PMID:26851100

  14. SEI: An update

    NASA Technical Reports Server (NTRS)

    Peach, Lewis L., Jr.

    1991-01-01

    An update on the Space Exploration Initiative (SEI) is given in viewgraph form. Topics covered include the key prerequisites of human exploration, project planning, Mars and lunar explorations, supporting technologies, near-term strategies for SEI, human support elements, and Space Station Freedom SEI accommodations.

  15. Community Update, 1999.

    ERIC Educational Resources Information Center

    Anderson, Julie, Ed.

    1999-01-01

    This document consists of nine issues (covering January through December 1999) of the newsletter "Community Update," containing articles on community and family involvement in education. Article topics include: new programs to help students prepare for college early; Vice President Al Gore announced the first-ever national Hispanic Education…

  16. Veterinary medicines update.

    PubMed

    2016-07-01

    The following information has been produced for Veterinary Record by the Veterinary Medicines Directorate (VMD) to provide an update for veterinary surgeons on recent changes to marketing authorisations for veterinary medicines in the UK and on other relevant issues. PMID:27365238

  17. Veterinary medicines update.

    PubMed

    2016-06-11

    The following information has been produced for Veterinary Record by the Veterinary Medicines Directorate (VMD) to provide an update for veterinary surgeons on recent changes to marketing authorisations for veterinary medicines in the UK and on other relevant issues. PMID:27288166

  18. Updating: Learning versus Supposing

    ERIC Educational Resources Information Center

    Zhao, Jiaying; Crupi, Vincenzo; Tentori, Katya; Fitelson, Branden; Osherson, Daniel

    2012-01-01

    Bayesian orthodoxy posits a tight relationship between conditional probability and updating. Namely, the probability of an event "A" after learning "B" should equal the conditional probability of "A" given "B" prior to learning "B". We examine whether ordinary judgment conforms to the orthodox view. In three experiments we found substantial…

  19. Supreme Court Update

    ERIC Educational Resources Information Center

    Taylor, Kelley R.

    2009-01-01

    "Chief Justice Flubs Oath." "Justice Ginsburg Has Cancer Surgery." At the start of this year, those were the news headlines about the U.S. Supreme Court. But January 2009 also brought news about key education cases--one resolved and two others on the docket--of which school administrators should take particular note. The Supreme Court updates on…

  20. Cultural practices updates

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Cultural practice updates from 2013 included the effects of shredding in spring, residue management, periodic flooding, no-till fertilizer applications, and billet planting on cane tonnage and sugar yield. Shredding, whether high or low, had little impacts in 2013. However, burning following shreddi...

  1. Southern Horticultural Lab Update

    Technology Transfer Automated Retrieval System (TEKTRAN)

    This publication is a new quarterly update for members of the Mississippi Nursery and Landscape Association that is published quarterly in their association newsletter. Two other versions of this newsletter are being submitted to the Louisiana Nursery and Landscape Association (LALNLA) and the Alaba...

  2. Veterinary medicines update.

    PubMed

    2016-09-10

    The following information has been produced for Veterinary Record by the Veterinary Medicines Directorate (VMD) to provide an update for veterinary surgeons on recent changes to marketing authorisations for veterinary medicines in the UK and on other relevant issues. PMID:27609956

  3. Veterinary medicines update.

    PubMed

    2016-08-01

    The following information has been produced for Veterinary Record by the Veterinary Medicines Directorate (VMD) to provide an update for veterinary surgeons on recent changes to marketing authorisations for veterinary medicines in the UK and on other relevant issues. PMID:27493045

  4. Community Update, 2001.

    ERIC Educational Resources Information Center

    Ashby, Nicole, Ed.

    2001-01-01

    This document consists of 10 issues (covering January through December 2000) of the newsletter, "Community Update," which features articles on community and family involvement in education. In addition to the articles, each issue (except the Special Issue) includes a preview of the month's Satellite Town Meeting; events and information discussed…

  5. 76 FR 72955 - Wyeth Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application for MYLOTARG

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-28

    ... the treatment of patients with CD33-positive acute myeloid leukemia in first relapse who were 60 years... diagnosed acute myelogenous leukemia failed to verify clinical benefit of MYLOTARG and raised...

  6. Carcinogenicity assessments of biotechnology-derived pharmaceuticals: a review of approved molecules and best practice recommendations.

    PubMed

    Vahle, John L; Finch, Gregory L; Heidel, Shawn M; Hovland, David N; Ivens, Inge; Parker, Suezanne; Ponce, Rafael A; Sachs, Clifford; Steigerwalt, Ronald; Short, Brian; Todd, Marque D

    2010-06-01

    An important safety consideration for developing new therapeutics is assessing the potential that the therapy will increase the risk of cancer. For biotherapeutics, traditional two-year rodent bioassays are often not scientifically applicable or feasible. This paper is a collaborative effort of industry toxicologists to review past and current practice regarding carcinogenicity assessments of biotherapeutics and to provide recommendations. Publicly available information on eighty marketed protein biotherapeutics was reviewed. In this review, no assessments related to carcinogenicity or tumor growth promotion were identified for fifty-one of the eighty molecules. For the twenty-nine biotherapeutics in which assessments related to carcinogenicity were identified, various experimental approaches were employed. This review also discusses several key principles to aid in the assessment of carcinogenic potential, including (1) careful consideration of mechanism of action to identify theoretical risks, (2) careful investigation of existing data for indications of proliferative or immunosuppressive potential, and (3) characterization of any proliferative or immunosuppressive signals detected. Traditional two-year carcinogenicity assays should not be considered as the default method for assessing the carcinogenicity potential of biotherapeutics. If experimentation is considered warranted, it should be hypothesis driven and may include a variety of experimental models. Ultimately, it is important that preclinical data provide useful guidance in product labeling. PMID:20472697

  7. Strattera: An Important Update

    ERIC Educational Resources Information Center

    Coffey, Kenneth; Obringer, S. John

    2006-01-01

    An article published in the Fall 2004 issue of this journal discussed a recently approved drug, Strattera, which is used for children and adults with Attention Deficit Hyperactivity Disorder (ADHD). The advantages and disadvantages of this medication were discussed in detail. However, there are new concerns about the use of Strattera after it has…

  8. 99M-technetium labeled macroaggregated human serum albumin pharmaceutical

    DOEpatents

    Winchell, Harry S.; Barak, Morton; Van Fleet, III, Parmer

    1977-05-17

    A reagent comprising macroaggregated human serum albumin having dispersed therein particles of stannous tin and a method for instantly making a labeled pharmaceutical therefrom, are disclosed. The labeled pharmaceutical is utilized in organ imaging.

  9. NON-TRADITIONAL RESPONSES TO PHARMACEUTICALS IN AQUATIC ECOSYSTEMS

    EPA Science Inventory

    Quantitation of human and veterinary pharmaceuticals in environmental matrices has resulted in pharmaceuticals in the environment receiving unprecedented attention from the scientific community. Aquatic hazard assessments often use quantitative structure activity relationships an...

  10. Risks to aquatic organisms posed by human pharmaceutical use

    EPA Science Inventory

    In order to help prioritize future research efforts within the US, risks associated with exposure to human prescription pharmaceutical residues in wastewater were estimated from marketing and pharmacological data. Masses of 371 active pharmaceutical ingredients (APIs) dispensed ...

  11. Predicting variability of aquatic concentrations of human pharmaceuticals

    EPA Science Inventory

    Potential exposure to active pharmaceutical ingredients (APIs) in the aquatic environment is a subject of ongoing concern. We recently estimated maximum likely potency-normalized exposure rates at the national level for several hundred commonly used human prescription pharmaceut...

  12. A Dialogic about Using Facebook Status Updates for Education Research: A PhD Student's Journey

    ERIC Educational Resources Information Center

    Barnes, Naomi; Penn-Edwards, Sorrel; Sim, Cheryl

    2015-01-01

    Facebook status updates provided the data for a study about the transition learning experiences of 1st-year university students. Strict ethical guidelines were proposed by the PhD researcher from the outset of the study. Anonymity was considered important for the approved ethical clearance for both the university and the participants.…

  13. 46 CFR 308.6 - Period of interim binders, updating application information and new applications.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... TRANSPORTATION EMERGENCY OPERATIONS WAR RISK INSURANCE General § 308.6 Period of interim binders, updating... Transportation's authority to provide such insurance has been extended and is continuous. (b) Assureds under.... (Approved by the Office of Management and Budget under control number 2133-0011)...

  14. 77 FR 202 - Federal Acquisition Regulation; Updated Financial Accounting Standards Board Accounting References

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-03

    ..., and NASA published a proposed rule in the Federal Register at 76 FR 8989 on February 16, 2011, to... information collection requirements that require the approval of the Office of Management and Budget under the... 9000-AM00 Federal Acquisition Regulation; Updated Financial Accounting Standards Board...

  15. 78 FR 76148 - Updated OGE Senior Executive Service Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-16

    ... Performance Review Board as it was most recently published at 77 FR 64521 (October 22, 2012). Approved... From the Federal Register Online via the Government Publishing Office OFFICE OF GOVERNMENT ETHICS Updated OGE Senior Executive Service Performance Review Board AGENCY: Office of Government Ethics...

  16. 77 FR 64521 - Updated OGE Senior Executive Service Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-22

    ... it was most recently published at 76 FR 60840 (September 30, 2011). Approved: October 11, 2012. Don W... From the Federal Register Online via the Government Publishing Office OFFICE OF GOVERNMENT ETHICS Updated OGE Senior Executive Service Performance Review Board AGENCY: Office of Government Ethics...

  17. 76 FR 60840 - Updated OGE Senior Executive Service Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-30

    ... it was most recently published at 75 FR 62540 (October 12, 2010). Approved: September 26, 2011. Don W... From the Federal Register Online via the Government Publishing Office OFFICE OF GOVERNMENT ETHICS Updated OGE Senior Executive Service Performance Review Board AGENCY: Office of Government Ethics...

  18. 75 FR 62540 - Updated OGE Senior Executive Service Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-12

    ... published at 73 FR 53250-53251 (September 15, 2008). Approved: October 5, 2010. Robert I. Cusick, Director... From the Federal Register Online via the Government Publishing Office OFFICE OF GOVERNMENT ETHICS Updated OGE Senior Executive Service Performance Review Board AGENCY: Office of Government Ethics...

  19. New Approaches in International Guidelines for Genetic Toxicology Assays: Latest Updates on OECD Guidelines

    EPA Science Inventory

    In March 2010, the 22nd meeting of the Working Group of National Coordinators of the OECD Test Guidelines Programme (WNT) approved a project for updating the Test Guidelines on genotoxicity, with Canada, the Netherlands, France and the USA identified as lead countries for this wo...

  20. International Dermatology Outcome Measures Initiative as Applied to Psoriatic Disease Outcomes: An Update.

    PubMed

    Merola, Joseph F; Armstrong, April W; Saraiya, Ami; Latella, John; Garg, Amit; Callis Duffin, Kristina; Gottlieb, Alice B

    2016-05-01

    Previous publications have described the International Dermatology Outcome Measures (IDEOM) group, comprising patients, physicians, health economists, participating pharmaceutical industry partners, payers, and regulatory agencies. The goal of IDEOM is to create patient-centered, validated measures of dermatologic disease progression and treatment efficacy for use in both clinical trials and clinical practice. We provide an update of IDEOM activities as of our 2015 IDEOM meeting in Washington, DC, USA. PMID:27134269

  1. Key issues in the pharmaceutical industry: consequences on R&D.

    PubMed

    Malik, Nafees N

    2009-01-01

    Drug discovery is hard, and is becoming progressively harder, with the passage of time! No other field has to handle such an interplay of scientific, fiscal and political factors. The rewards are, nonetheless, worth it: people now live healthier and longer lives than at any point of time in the past. Times are, however, hard for pharmaceutical companies: research and development (R&D) costs are spiralling out of control. New drug approvals, on the other hand, have hit a record low; and the situation is expected to worsen, now that the FDA seems to be exhibiting stricter drug approval standards. Other issues also exacerbate circumstances: huge numbers of blockbuster medicines, which drugmakers rely on to generate their incomes, are coming off patent, and generic competition is intensifying. Both public and investor confidence in the industry have fallen drastically owing to rising drug prices, product safety concerns and late-stage clinical trial failures. This article discusses the key issues that pharmaceutical companies face and in particular the implications they have for the R&D process. I finish by suggesting how drugmakers should change their R&D strategies to succeed. PMID:23480332

  2. Restrictions on pharmaceutical detailing reduced off-label prescribing of antidepressants and antipsychotics in children.

    PubMed

    Larkin, Ian; Ang, Desmond; Avorn, Jerry; Kesselheim, Aaron S

    2014-06-01

    The treatment of pediatric depression is controversial because it includes substantial prescribing of drugs for uses that have not been approved by the Food and Drug Administration ("off label") and are not evidence based. Some academic medical centers (AMCs) restrict "detailing" by pharmaceutical sales representatives, or the promoting of drugs directly to physicians via sales calls, to reduce the effect of such marketing on physician prescribing. With data from thirty-one geographically diverse AMCs and their affiliated hospitals, we used a difference-in-differences model to estimate the effect of anti-detailing policies on off-label prescribing of antidepressants and antipsychotics by pediatricians and by child and adolescent psychiatrists in the period January 2006-June 2009. We found that after the introduction of such policies, prescriptions for off-label use of promoted drugs fell by 11 percent, consistent with the ongoing presence of off-label marketing to physicians. Prescriptions for on-label use of promoted drugs fell by 34 percent after the adoption of the policies. Conversely, prescriptions for on-label use of nonpromoted drugs rose by 14 percent, and those for off-label use of nonpromoted drugs rose by 35 percent. These results suggest that pharmaceutical sales representatives promoted drugs not approved for pediatric use and that policies that restrict detailing by those representatives reduced such off-label prescribing. PMID:24889951

  3. An Innovative Pharmaceutical Care Practical Course

    ERIC Educational Resources Information Center

    Bulatova, N. R.; Aburuz, S.; Yousef, A. M.

    2007-01-01

    The innovative practical course was developed to improve the students' ability to acquire pharmaceutical care skills. The primary components of the course were in-school training using small group discussions and hospital experience including identification, analysis, prevention and resolution of drug-therapy problems, patient counseling on their…

  4. Pharmaceutical Applications of Ion-Exchange Resins

    ERIC Educational Resources Information Center

    Elder, David

    2005-01-01

    The historical uses of ion-exchanged resins and a summary of the basic chemical principles involved in the ion-exchanged process are discussed. Specific applications of ion-exchange are provided that include drug stabilization, pharmaceutical excipients, taste-masking agents, oral sustained-release products, topical products for local application…

  5. Pharmaceutical knowledge governance: a human rights perspective.

    PubMed

    Lemmens, Trudo

    2013-01-01

    Industry control over the production and distribution of pharmaceutical safety and efficacy data has become a serious public health and health care funding concern. Various recent scandals, several involving the use of flawed representations of scientific data in the most influential medical journals, highlight the urgency of enhancing pharmaceutical knowledge governance. This paper analyzes why this is a human rights concern and what difference a human rights analysis can make. The paper first identifies the challenges associated with the current knowledge deficit. It then discusses, based on an analysis of case law, how various human rights associated interests can be invoked to support the claim that states have an obligation to actively contribute to independent knowledge governance, for example through ensuring clinical trials transparency. The paper further discusses a conceptual use of human rights, as a methodology which requires a comprehensive analysis of the different interwoven historical, economic, cultural, and social factors that contribute to the problem. Such an analysis reveals that historically grown drug regulations have, in fact, contributed directly to industry control over pharmaceutical knowledge production. This type of finding should inform needed reforms of drug regulation. The paper ends with a recommendation for a comprehensive global response to the problem of pharmaceutical knowledge governance. PMID:23581664

  6. Opportunities and responsibilities in pharmaceutical care.

    PubMed

    Hepler, C D; Strand, L M

    1990-03-01

    Pharmacy's opportunity to mature as a profession by accepting its social responsibility to reduce preventable drug-related morbidity and mortality is explored. Pharmacy has shed the apothecary role but has not yet been restored to its erst-while importance in medical care. It is not enough to dispense the correct drug or to provide sophisticated pharmaceutical services; nor will it be sufficient to devise new technical functions. Pharmacists and their institutions must stop looking inward and start redirecting their energies to the greater social good. Some 12,000 deaths and 15,000 hospitalizations due to adverse drug reactions (ADRs) were reported to the FDA in 1987, and many went unreported. Drug-related morbidity and mortality are often preventable, and pharmaceutical services can reduce the number of ADRs, the length of hospital stays, and the cost of care. Pharmacists must abandon factionalism and adopt patient-centered pharmaceutical care as their philosophy of practice. Changing the focus of practice from products and biological systems to ensuring the best drug therapy and patient safety will raise pharmacy's level of responsibility and require philosophical, organizational, and functional changes. It will be necessary to set new practice standards, establish cooperative relationships with other health-care professions, and determine strategies for marketing pharmaceutical care. Pharmacy's reprofessionalization will be completed only when all pharmacists accept their social mandate to ensure the safe and effective drug therapy of the individual patient. PMID:2316538

  7. New pharmaceuticals in inflammatory bowel disease

    PubMed Central

    Łodyga, Michał; Eder, Piotr; Bartnik, Witold; Gonciarz, Maciej; Kłopocka, Maria; Linke, Krzysztof; Małecka-Panas, Ewa; Radwan, Piotr

    2015-01-01

    This paper complements the previously published Guidelines of the Working Group of the Polish Society of Gastroenterology and former National Consultant in Gastroenterology regarding the management of patients with Crohn's disease and ulcerative colitis. Attention was focused on the new pharmaceutical recently registered for inflammatory bowel disease treatment. PMID:26557934

  8. An Interdisciplinary Course in Pharmaceutical Advertising.

    ERIC Educational Resources Information Center

    Grieshaber, Larry D.; And Others

    1980-01-01

    A course in pharmaceutical product merchandising offered at the St. Louis College of Pharmacy incorporated as its three major components the development of a one-page print advertisement, a recorded radio commercial, and a videotape commercial series. Student evaluations were based on performance rather than effort. (MSE)

  9. Pharmaceuticals and Hormones in the Environment

    EPA Science Inventory

    Some of the earliest initial reports from Europe and the United States demonstrated that a variety of pharmaceuticals and hormones could be found in surface waters, source waters, drinking water, and influents and effluents from wastewater treatment plants (WWTPs). It is unknown...

  10. [Archeology of the radio pharmaceutical advertisement].

    PubMed

    Lefebvre, Thierry

    2002-01-01

    After Second World War, a debate sets in France the partisans and the detractors of the radio advertisement, in particular pharmaceutical advertisement. In this article, the author revises campaigns led, during the thirties, by Robert Desnos for Armand Salacrou. PMID:12731488

  11. Pharmaceutical drugs chatter on Online Social Networks.

    PubMed

    Wiley, Matthew T; Jin, Canghong; Hristidis, Vagelis; Esterling, Kevin M

    2014-06-01

    The ubiquity of Online Social Networks (OSNs) is creating new sources for healthcare information, particularly in the context of pharmaceutical drugs. We aimed to examine the impact of a given OSN's characteristics on the content of pharmaceutical drug discussions from that OSN. We compared the effect of four distinguishing characteristics from ten different OSNs on the content of their pharmaceutical drug discussions: (1) General versus Health OSN; (2) OSN moderation; (3) OSN registration requirements; and (4) OSNs with a question and answer format. The effects of these characteristics were measured both quantitatively and qualitatively. Our results show that an OSN's characteristics indeed affect the content of its discussions. Based on their information needs, healthcare providers may use our findings to pick the right OSNs or to advise patients regarding their needs. Our results may also guide the creation of new and more effective domain-specific health OSNs. Further, future researchers of online healthcare content in OSNs may find our results informative while choosing OSNs as data sources. We reported several findings about the impact of OSN characteristics on the content of pharmaceutical drug discussion, and synthesized these findings into actionable items for both healthcare providers and future researchers of healthcare discussions on OSNs. Future research on the impact of OSN characteristics could include user demographics, quality and safety of information, and efficacy of OSN usage. PMID:24637141

  12. Deep pharma: psychiatry, anthropology, and pharmaceutical detox.

    PubMed

    Oldani, Michael

    2014-06-01

    Psychiatric medication, or psychotropics, are increasingly prescribed for people of all ages by both psychiatry and primary care doctors for a multitude of mental health and/or behavioral disorders, creating a sharp rise in polypharmacy (i.e., multiple medications). This paper explores the clinical reality of modern psychotropy at the level of the prescribing doctor and clinical exchanges with patients. Part I, Geographies of High Prescribing, documents the types of factors (pharmaceutical-promotional, historical, cultural, etc.) that can shape specific psychotropic landscapes. Ethnographic attention is focused on high prescribing in Japan in the 1990s and more recently in the Upper Peninsula of Michigan, in the US. These examples help to identify factors that have converged over time to produce specific kinds of branded psychotropic profiles in specific locales. Part II, Pharmaceutical Detox, explores a new kind of clinical work being carried out by pharmaceutically conscious doctors, which reduces the number of medications being prescribed to patients while re-diagnosing their mental illnesses. A high-prescribing psychiatrist in southeast Wisconsin is highlighted to illustrate a kind of med-checking taking place at the level of individual patients. These various examples and cases call for a renewed emphasis by anthropology to critically examine the "total efficacies" of modern pharmaceuticals and to continue to disaggregate mental illness categories in the Boasian tradition. This type of detox will require a holistic approach, incorporating emergent fields such as neuroanthropology and other kinds of creative collaborations. PMID:24700144

  13. Developing Closer Ties with the Pharmaceutical Industry.

    ERIC Educational Resources Information Center

    Reid, Gregor; Hoddinott, Susan

    1991-01-01

    The need for research administrators to understand and appreciate the pharmaceutical industry's research and development environment is discussed, using examples from Canada. The research administrator's role in the technology transfer process and implications for faculty are examined. Ways to build closer school-industry ties are discussed. (MSE)

  14. Drug Information Residency Rotation with Pharmaceutical Industry.

    ERIC Educational Resources Information Center

    Cramer, Richard L.

    1986-01-01

    Program objectives of a drug information rotation at the Upjohn Company include improving communication between the pharmaceutical industry and hospital pharmacy/academia, exposing the resident to the challenges the industry encounters, improving proficiency in drug information practice, and providing insight into the working relationships of…

  15. The Pharmaceutical Care Movement: Opportunities for Collaboration.

    ERIC Educational Resources Information Center

    Temple, Thomas R.

    1996-01-01

    Areas in which pharmacy educators and practitioners can collaborate to hasten pharmacy curriculum development are outlined, including: state and regional centers for operationalizing the pharmaceutical care concept; training, formal resource programs for pharmacists; research advisory boards; public education; links with medical community;…

  16. General public knowledge, perceptions and practice towards pharmaceutical drug advertisements in the Western region of KSA.

    PubMed

    Al-Haddad, Mahmoud S; Hamam, Fayez; Al-Shakhshir, Sami M

    2014-04-01

    This study aims to examine general public knowledge and behavior toward pharmaceutical advertisements in the Western part of KSA. A cross sectional convenience sampling technique was used in this study. A total of 1445 valid questionnaires were received and analyzed using SPSS version 16 at alpha value of 0.05. Majority of respondents were aware of different types of drugs to be advertised and drug advertisements should seek approval from the health authorities. Television and Internet showed the highest effect on consumers. Almost half of the participants preferred an advertised drug over non-advertised one. Most of the respondents indicated that the quality of frequently advertised drugs is not better than those prescribed by the doctors. Majority of participants had positive beliefs toward advertised drugs concerning their role in education and spreading of awareness among the public. Pharmaceutical advertisements harm the doctor-patient relationship as evidenced by one-third of the investigated sample. Moreover, majority of the participants mentioned that they would consult another doctor or even change the current doctor if he/she refused to prescribe an advertised medication. Results of this study could be used to develop awareness programs for the general public and try to enforce the regulations and policies to protect the general public and patients from the business oriented pharmaceutical companies and drug suppliers. PMID:24648823

  17. Negotiating Pharmaceutical Prices: A Change in Chinese Health Policy.

    PubMed

    Costello, Michael M

    2016-01-01

    Like many other nations, China believed the key to restricting national health expenditures for pharmaceuticals was the use of governmentally imposed price caps. Given the recent growth in pharmaceutical expenditures, China is moving away from price caps to a new process that includes locally negotiated prices in the hope that such price competition will lower national pharmaceutical pricing. The success of this policy endeavour will depend significantly on managing other aspects of pharmaceutical purchasing. PMID:27358014

  18. Pharmaceuticals as Groundwater Tracers - Applications and Limitations

    NASA Astrophysics Data System (ADS)

    Scheytt, T. J.; Mersmann, P.; Heberer, T.

    2003-12-01

    Pharmaceutically active substances and metabolites are found at concentrations up to the microgram/L-level in groundwater samples from the Berlin (Germany) area and from several other places world wide. Among the compounds detected in groundwater are clofibric acid, propyphenazone, diclofenac, ibuprofen, and carbamazepine. Clofibric acid, the active metabolite of clofibrate and etofibrate (blood lipid regulators) is detected in groundwater at maximum concentrations of 7300 ng/L. Among the most important input paths of drugs are excretion and disposal into the sewage system. Groundwater contamination is likely to be due to leaky sewage systems, influent streams, bank filtration, and irrigation with effluent water from sewage treatment plants. There are no known natural sources of the above mentioned pharmaceuticals. The use of pharmaceuticals as tracers may include: (a) Quantification of infiltration from underground septic tanks (b) Detection of leaky sewage systems / leaky sewage pipes (c) Estimation of the effectiveness of sewage treatment plants (d) Identification of transport pathways of other organic compounds (e) Quantification of surface water / groundwater interaction (f) Characterization of the biodegradation potential. The use of pharmaceuticals as tracers is limited by variations in input. These variations depend on the amount of drugs prescribed and used in the study area, the social structure of the community, the amount of hospital discharge, and temporal concentration variations. Furthermore, the analysis of trace amounts of pharmaceuticals is sophisticated and expensive and may therefore limit the applicability of pharmaceuticals as tracers. Finally, the transport and degradation behavior of pharmaceuticals is not fully understood. Preliminary experiments in the laboratory were conducted using sediment material and groundwater from the Berlin area to evaluate the transport and sorption behavior of selected drugs. Results of the column experiments

  19. 40 CFR 52.1922 - Approval status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Oklahoma § 52.1922 Approval status. With the exceptions set forth in this subpart, the Administrator approves Oklahoma's plan for the attainment...

  20. 40 CFR 52.1922 - Approval status.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Oklahoma § 52.1922 Approval status. With the exceptions set forth in this subpart, the Administrator approves Oklahoma's plan for the attainment...

  1. 40 CFR 52.1922 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Oklahoma § 52.1922 Approval status. With the exceptions set forth in this subpart, the Administrator approves Oklahoma's plan for the attainment...

  2. 40 CFR 52.1922 - Approval status.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Oklahoma § 52.1922 Approval status. With the exceptions set forth in this subpart, the Administrator approves Oklahoma's plan for the attainment...

  3. 40 CFR 52.1922 - Approval status.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Oklahoma § 52.1922 Approval status. With the exceptions set forth in this subpart, the Administrator approves Oklahoma's plan for the attainment...

  4. 40 CFR 52.2722 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Puerto Rico § 52.2722 Approval status. With the exceptions set forth in this subpart, the Administrator approves Puerto Rico's plans for...

  5. 40 CFR 52.1772 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) North Carolina § 52.1772 Approval status. (a) With the exceptions set forth in this subpart, the Administrator approves North Carolina's plans...

  6. 40 CFR 52.2172 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) South Dakota § 52.2172 Approval status. With the exceptions set forth in this subpart, the Administrator approves South Dakota's plan as...

  7. 40 CFR 52.1622 - Approval status.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) New Mexico § 52.1622 Approval status. With the exceptions set forth in this subpart, the Administrator approves New Mexico's plan for...

  8. 40 CFR 52.1622 - Approval status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) New Mexico § 52.1622 Approval status. With the exceptions set forth in this subpart, the Administrator approves New Mexico's plan for...

  9. 40 CFR 52.1622 - Approval status.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) New Mexico § 52.1622 Approval status. With the exceptions set forth in this subpart, the Administrator approves New Mexico's plan for...

  10. 40 CFR 52.1622 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) New Mexico § 52.1622 Approval status. With the exceptions set forth in this subpart, the Administrator approves New Mexico's plan for...

  11. 40 CFR 52.1622 - Approval status.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) New Mexico § 52.1622 Approval status. With the exceptions set forth in this subpart, the Administrator approves New Mexico's plan for...

  12. 40 CFR 52.1673 - Approval status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) New York § 52.1673 Approval status. (a) With the exceptions set forth in this section, the Administrator approves the New York State...

  13. 40 CFR 52.1673 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) New York § 52.1673 Approval status. (a) With the exceptions set forth in this section, the Administrator approves the New York State...

  14. 40 CFR 52.1223 - Approval status.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Minnesota § 52.1223 Approval status. With the exceptions set forth in this subpart, the Administrator approves Minnesota's plans for the attainment...

  15. 40 CFR 52.1223 - Approval status.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Minnesota § 52.1223 Approval status. With the exceptions set forth in this subpart, the Administrator approves Minnesota's plans for the attainment...

  16. 40 CFR 52.1223 - Approval status.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Minnesota § 52.1223 Approval status. With the exceptions set forth in this subpart, the Administrator approves Minnesota's plans for the attainment...

  17. 40 CFR 52.1223 - Approval status.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Minnesota § 52.1223 Approval status. With the exceptions set forth in this subpart, the Administrator approves Minnesota's plans for the attainment...

  18. 40 CFR 52.1223 - Approval status.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS (CONTINUED) Minnesota § 52.1223 Approval status. With the exceptions set forth in this subpart, the Administrator approves Minnesota's plans for the attainment...

  19. Informed consent: Enforcing pharmaceutical companies' obligations abroad.

    PubMed

    Lee, Stacey B

    2010-01-01

    The past several years have seen an evolution in the obligations of pharmaceutical companies conducting clinical trials abroad. Key players, such as international human rights organizations, multinational pharmaceutical companies, the United States government and courts, and the media, have played a significant role in defining these obligations. This article examines how such obligations have developed through the lens of past, present, and future recommendations for informed consent protections. In doing so, this article suggests that, no matter how robust obligations appear, they will continue to fall short of providing meaningful protection until they are accompanied by a substantive enforcement mechanism that holds multinational pharmaceutical companies accountable for their conduct. Issues of national sovereignty, particularly in the United States, will continue to prevent meaningful enforcement by an international tribunal or through one universally adopted code of ethics. This article argues that, rather than continuing to pursue an untenable international approach, the Alien Torts Statute (ATS) offers a viable enforcement mechanism, at least for US-based pharmaceutical companies. Recent federal appellate court precedent interpreting the ATS provides the mechanism for granting victims redress and enforcing accountability of sponsors (usually pharmaceutical companies and research and academic institutions) for informed consent misconduct. Substantive human rights protections are vital in order to ensure that every person can realize the "right to health." This article concludes that by building on the federal appellate court's ATS analysis, which grants foreign trial participants the right to pursue claims of human rights violations in US courts, a mechanism can be created for enforcing not only substantive informed consent, but also human rights protections. PMID:20930251

  20. Effective executive management in the pharmaceutical industry.

    PubMed

    Tran, Hoang; Kleiner, Brian H

    2005-01-01

    Along with the boom in information technology and vast development in genomic and proteomic discoveries, the pharmaceutical and biotech industries have been provided the means and tools to create a new page in medicinal history. They are now able to alter the classic ways to cure complex diseases thanks to the completion of the human genome project. To be able to compete in this industry, pharmaceutical management has to be effective not only internally but also externally in socially acceptable conduct. The first department that requires focus is marketing and sales. As the main driving force to increase revenues and profits, marketing and sales employees should be highly motivated by compensation. Also, customer relationships should be maintained for long-term gain. As important as marketing, research and development requires the financial support as well as the critical decision making to further expand the product pipeline. Similarly, finance and technologies should be adequately monitored and invested to provide support as well as prepare for future expansion. On top of that, manufacturing processes and operations are operated per quality systems and FDA guidelines to ensure high quality. Human Resources, on the other hand, should carry the managing and motivation from upper management through systematic recruitment, adequate training, and fair compensation. Moreover, effective management in a pharmaceutical would also require the social welfare and charity to help patients who cannot afford the treatment as well as improving the organization's image. Last but not least, the management should also prepare for the globalization of the industry. Inevitably, large pharmaceutical companies are merging with each other or acquiring smaller companies to enhance the competitive advantages as well as expand their product mix. For effectiveness in a pharmaceutical industry, management should focus more than just the daily routine tasks and short-term goals. Rather, they

  1. Is the pharmaceutical market in Bulgaria innovative?

    PubMed

    Stoimenova, A; Stankova, M; Samev, K; Petrova, G

    2003-09-01

    After the turn to market oriented economy a lot of drugs were authorized for sale in the East European countries. Because of the limited resources of these countries, mainly generic or brand generic products were licensed. The number of the patented drugs on the market could be used as measure of the market attractiveness to the R&D producers. The study shows the analysis of the innovativeness of the Bulgarian drug market comparing the registration and the patient activity of the producers. The number of the authorized products for five years period (1990-2000) and share of the patented products were investigated. During the observed period the number of newly authorized pharmaceuticals increased almost seven times from 800 (650 INN) to 6000 (2000 INN) dosage forms. The prevailing part of the newly registered drugs was found to be brand generics and possess only trade name protection. The share of drugs that are patented is less than five percent of all newly registered medicines, and among the fifty most commonly prescribed and sold medicines between 1996-2000, only 0.5 percent of drugs were patented. Obviously the Bulgarian pharmaceutical market is very competitive but not that attractive for most of the R&D producers. In general the registration of the patent protected products is increasing during the years and especially after harmonization of the related legislation with the EU requirements. The patent activity of the pharmaceutical companies regarding newly authorized drugs is influenced by the structure of morbidity and population. During the last two years the patent activity is increasing and is oriented mainly towards the protection of newly authorized drugs or pharmaceutical forms and obligatory registration of trademarks for the privatized Bulgarian pharmaceutical manufacturers. PMID:14677267

  2. Biosimilars approval process.

    PubMed

    Zuñiga, Leyre; Calvo, Begoña

    2010-04-01

    For similar biological medicinal products, the so-called biosimilars, clinical trials are required rather than just the bioequivalence studies required to support the registration of a generic small molecule drug product. The EU Directive 2001/83/EC, as amended, stated that where a biological medicinal product which is similar to a reference biological product, does not meet the conditions in the definition of generic medicinal products the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided. The challenge is to determine the exact nature of the non-clinical and clinical programme required to gain regulatory approval. The applicant is encouraged to provide a detailed description of the strategy used to demonstrate the biosimilar and the reference product have similar profiles in terms of quality, safety and efficacy. The extent to which comparability can be proven will have quite an impact on how many non-clinical and clinical studies the biosimilar applicant will be required to conduct. The dossier submitted by the applicant to the EMEA should cover all aspects of the comparability assessment and must include data on possible unwanted immune reactions to the therapeutic protein. Post-marketing pharmacovigilance plans are also expected to be included in the biosimilar dossier. PMID:19925842

  3. Are pharmaceuticals potent environmental pollutants? Part I: environmental risk assessments of selected active pharmaceutical ingredients.

    PubMed

    Carlsson, Carina; Johansson, Anna-Karin; Alvan, Gunnar; Bergman, Kerstin; Kühler, Thomas

    2006-07-01

    As part of achieving national environmental goals, the Swedish Government commissioned an official report from the Swedish Medical Products Agency on environmental effects of pharmaceuticals. Considering half-lives/biodegradability, environmental occurrence, and Swedish sales statistics, 27 active pharmaceutical ingredients were selected for environmental hazard and risk assessments. Although there were large data gaps for many of the compounds, nine ingredients were identified as dangerous for the aquatic environment. Only the sex hormones oestradiol and ethinyloestradiol were considered to be associated with possible aquatic environmental risks. We conclude that risk for acute toxic effects in the environment with the current use of active pharmaceutical ingredients is unlikely. Chronic environmental toxic effects, however, cannot be excluded due to lack of chronic ecotoxicity data. Measures to reduce potential environmental impact posed by pharmaceutical products must be based on knowledge on chronic ecotoxic effects of both active pharmaceutical ingredients as well as excipients. We believe that the impact pharmaceuticals have on the environment should be further studied and be given greater attention such that informed assessments of hazards as well as risks can be done. PMID:16257037

  4. A pharmaceutical care challenge: recruiting, training, and retaining pharmaceutical care practitioners.

    PubMed

    Hatwig, C A; Crane, V S; Hayman, J N

    1993-10-01

    We do not claim to have all the answers when it comes to implementing an ideal pharmaceutical care model. We are not even sure what all the characteristics of such a model should be. We have recognized, based on our interpretation of the model, that meeting the demands of pharmaceutical care will require changes and advanced skills in our staff. We continue to work in creating an environment where the concept of pharmaceutical care can flourish. Our department has focused on defining and then providing pharmaceutical care through individual practitioners and patient care teams. More employee empowerment with less management control was the key to facilitating initial phases in our pharmaceutical care model. A successful orientation process has further enhanced our abilities to hire new graduates and/or experienced practitioners for our open positions. We believe we have taken some significant first steps toward recruiting, training, and developing our staff to become competent and satisfied with their newly developing role as pharmaceutical care practitioners. PMID:10129979

  5. Updated treatment algorithm of pulmonary arterial hypertension.

    PubMed

    Galiè, Nazzareno; Corris, Paul A; Frost, Adaani; Girgis, Reda E; Granton, John; Jing, Zhi Cheng; Klepetko, Walter; McGoon, Michael D; McLaughlin, Vallerie V; Preston, Ioana R; Rubin, Lewis J; Sandoval, Julio; Seeger, Werner; Keogh, Anne

    2013-12-24

    The demands on a pulmonary arterial hypertension (PAH) treatment algorithm are multiple and in some ways conflicting. The treatment algorithm usually includes different types of recommendations with varying degrees of scientific evidence. In addition, the algorithm is required to be comprehensive but not too complex, informative yet simple and straightforward. The type of information in the treatment algorithm are heterogeneous including clinical, hemodynamic, medical, interventional, pharmacological and regulatory recommendations. Stakeholders (or users) including physicians from various specialties and with variable expertise in PAH, nurses, patients and patients' associations, healthcare providers, regulatory agencies and industry are often interested in the PAH treatment algorithm for different reasons. These are the considerable challenges faced when proposing appropriate updates to the current evidence-based treatment algorithm.The current treatment algorithm may be divided into 3 main areas: 1) general measures, supportive therapy, referral strategy, acute vasoreactivity testing and chronic treatment with calcium channel blockers; 2) initial therapy with approved PAH drugs; and 3) clinical response to the initial therapy, combination therapy, balloon atrial septostomy, and lung transplantation. All three sections will be revisited highlighting information newly available in the past 5 years and proposing updates where appropriate. The European Society of Cardiology grades of recommendation and levels of evidence will be adopted to rank the proposed treatments. PMID:24355643

  6. [Update on anticancer drugs].

    PubMed

    Roila, Fausto; Ballatori, Enzo

    2014-01-01

    Update on anticancer drugs. A thorough review of the clinical trials published over the last two years in major medical and oncological journals on a comprehensive spectrum of oncological conditions aims to provide at the same time (as the authors are well known representatives of the critical and complementary competences of clinical care and research methodology) an interesting double opportunity of update on: a) what is truly (i.e.documented and reliable) innovative and deserves adoption in daily care,vs what is either purely suggestive or clearly misleading; b) what are the methological, concrete, simple rules to observe in a field which is certainly moving fast, but at the same time generates highly controversial behaviors in research as well as in daily practices. The accompanying editorial (pag 60-63) further illustrates the way and the yield of using this material and approach both in the areas of nursing sciences and practice. PMID:25002061

  7. Sensors, Update 12

    NASA Astrophysics Data System (ADS)

    Baltes, Henry; Fedder, Gary K.; Korvink, Jan G.

    2003-04-01

    Sensors Update ensures that you stay at the cutting edge of the field. Built upon the series Sensors, it presents an overview of highlights in the field. Coverage includes current developments in materials, design, production, and applications of sensors, signal detection and processing, as well as new sensing principles. Each volume is divided into three sections. Sensor Technology, reviews highlights in applied and basic research, Sensor Applications, covers new or improved applications of sensors, Sensor Markets, provides a survey of suppliers and market trends for a particular area. With this unique combination of information in each volume, Sensors Update will be of value for scientists and engineers in industry and at universities, to sensors developers, distributors, and users.

  8. Sensors, Update 8

    NASA Astrophysics Data System (ADS)

    Baltes, Henry; Göpel, Wolfgang; Hesse, Joachim

    2001-02-01

    Sensors Update ensures that you stay at the cutting edge of the field. Built upon the series Sensors, it presents an overview of highlights in the field. Coverage includes current developments in materials, design, production, and applications of sensors, signal detection and processing, as well as new sensing principles. Each volume is divided into three sections: Sensor Technology reviews highlights in applied and basic research, while Sensor Applications covers new or improved applications of sensors, and Sensor Markets provides a survey of suppliers and market trends for a particular area. With this unique combination of information in each volume, Sensors Update will be invaluable to scientists and engineers in industry and at universities, to sensors developers, distributors, and users.

  9. Sensors, Update 2

    NASA Astrophysics Data System (ADS)

    Baltes, Henry; Göpel, Wolfgang; Hesse, Joachim

    1996-10-01

    Sensors Update ensures that you stay at the cutting edge of the field. Built upon the series Sensors, it presents an overview of highlights in the field. Coverage includes current developments in materials, design, production, and applications of sensors, signal detection and processing, as well as new sensing principles. Furthermore, the sensor market as well as peripheral aspects such as standards are covered. Each volume is divided into four sections. Sensor Technology, reviews highlights in applied and basic research, Sensor Applications, covers new or improved applications of sensors, Sensor Markets, provides a survey of suppliers and market trends for a particular area. With this unique combination of information in each volume, Sensors Update will be of value for scientists and engineers in industry and at universities, to sensors developers, distributors, and users.

  10. Sensors, Update 11

    NASA Astrophysics Data System (ADS)

    Baltes, Henry; Fedder, Gary K.; Korvink, Jan G.

    2003-03-01

    Sensors Update ensures that you stay at the cutting edge of the field, presenting the current highlights of sensor and related microelectromechanical systems technology. Coverage includes most recent developments in materials, design, production, and applications of sensors, signal detection and processing, as well as new sensing principles based on micro- and nanotechnology. Each volume is divided into three sections: Sensor Technology reviews highlights in applied and basic research, Sensor Applications covers new or improved applications of sensors and Sensor Markets provides a survey of suppliers and market trends for a particular area. With this unique combination of information in each volume, Sensors Update is of must-have value for scientists and engineers in industry and at universities, to sensors developers, distributors, and users.

  11. Sensors, Update 1

    NASA Astrophysics Data System (ADS)

    Baltes, Henry; Göpel, Wolfgang; Hesse, Joachim

    1996-12-01

    Sensors Update ensures that you stay at the cutting edge of the field. Built upon the series Sensors, it presents an overview of highlights in the field. Treatments include current developments in materials, design, production, and applications of sensors, signal detection and processing, as well as new sensing principles. Furthermore, the sensor market as well as peripheral aspects such as standards are covered. Each volume is divided into four sections. Sensor Technology, reviews highlights in applied and basic research, Sensor Applications, covers new or improved applications of sensors, Sensor Markets, provides an overview of suppliers and market trends for a particular section, and Sensor Standards, reviews recent legislation and requirements for sensors. With this unique combination of information in each volume, Sensors Update will be of value for scientists and engineers in industry and at universities, to sensors developers, distributors, and users.

  12. Sensors, Update 10

    NASA Astrophysics Data System (ADS)

    Baltes, Henry; Fedder, Gary K.; Korvink, Jan G.

    2002-04-01

    Sensors Update ensures that you stay at the cutting edge of the field. Built upon the series Sensors, it presents an overview of highlights in the field. Coverage includes current developments in materials, design, production, and applications of sensors, signal detection and processing, as well as new sensing principles. Each volume is divided into three sections. Sensor Technology, reviews highlights in applied and basic research, Sensor Applications, covers new or improved applications of sensors, Sensor Markets, provides a survey of suppliers and market trends for a particular area. With this unique combination of information in each volume, Sensors Update will be of value for scientists and engineers in industry and at universities, to sensors developers, distributors, and users.

  13. Sensors, Update 9

    NASA Astrophysics Data System (ADS)

    Baltes, Henry; Göpel, Wolfgang; Hesse, Joachim

    2001-10-01

    Sensors Update ensures that you stay at the cutting edge of the field. Built upon the series Sensors, it presents an overview of highlights in the field. Coverage includes current developments in materials, design, production, and applications of sensors, signal detection and processing, as well as new sensing principles. Each volume is divided into three sections. Sensor Technology, reviews highlights in applied and basic research, Sensor Applications, covers new or improved applications of sensors, Sensor Markets, provides a survey of suppliers and market trends for a particular area. With this unique combination of information in each volume, Sensors Update will be of value for scientists and engineers in industry and at universities, to sensors developers, distributors, and users.

  14. SIM-Lite Update

    NASA Technical Reports Server (NTRS)

    Shao, Michael

    2008-01-01

    Discussion focus on: SIM-Lite Instrument Update - 6m baseline, 50cm, approximately 900M cost; Technology Update - Systematic errors and floor; SIM-Lite terrestrial planet discovery capability; Double blind multiple planet study summary; and the changing landscape of exoplanet science and the role of SIM-Lite. Slides include technology to flight component engineering; instrumental systematic errors; ultra deep search for Earth clones; double blind test, astrometric detection of Earths in multiplanet systems; the current era of exoplanet science and where SIM-Lite fits in; the next frontier and where SIM-Lite fits in, why SIM is unique in discovering Earths; imaging planet status is uncertain without masses and ages; SIM role in establishing how planetary systems form and evolve; and SIM probes of broad planet mass range around young stars.

  15. Sequence History Update Tool

    NASA Technical Reports Server (NTRS)

    Khanampompan, Teerapat; Gladden, Roy; Fisher, Forest; DelGuercio, Chris

    2008-01-01

    The Sequence History Update Tool performs Web-based sequence statistics archiving for Mars Reconnaissance Orbiter (MRO). Using a single UNIX command, the software takes advantage of sequencing conventions to automatically extract the needed statistics from multiple files. This information is then used to populate a PHP database, which is then seamlessly formatted into a dynamic Web page. This tool replaces a previous tedious and error-prone process of manually editing HTML code to construct a Web-based table. Because the tool manages all of the statistics gathering and file delivery to and from multiple data sources spread across multiple servers, there is also a considerable time and effort savings. With the use of The Sequence History Update Tool what previously took minutes is now done in less than 30 seconds, and now provides a more accurate archival record of the sequence commanding for MRO.

  16. A Tool for Predicting Regulatory Approval After Phase II Testing of New Oncology Compounds.

    PubMed

    DiMasi, J A; Hermann, J C; Twyman, K; Kondru, R K; Stergiopoulos, S; Getz, K A; Rackoff, W

    2015-11-01

    We developed an algorithm (ANDI) for predicting regulatory marketing approval for new cancer drugs after phase II testing has been conducted, with the objective of providing a tool to improve drug portfolio decision-making. We examined 98 oncology drugs from the top 50 pharmaceutical companies (2006 sales) that first entered clinical development from 1999 to 2007, had been taken to at least phase II development, and had a known final outcome (research abandonment or regulatory marketing approval). Data on safety, efficacy, operational, market, and company characteristics were obtained from public sources. Logistic regression and machine-learning methods were used to provide an unbiased approach to assess overall predictability and to identify the most important individual predictors. We found that a simple four-factor model (activity, number of patients in the pivotal phase II trial, phase II duration, and a prevalence-related measure) had high sensitivity and specificity for predicting regulatory marketing approval. PMID:26239772

  17. 48 CFR 750.7105 - Approving authorities.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... CONTRACT MANAGEMENT EXTRAORDINARY CONTRACTUAL ACTIONS Extraordinary Contractual Actions To Protect Foreign Policy Interests of the United States 750.7105 Approving authorities. All authority to approve...

  18. Update on rufinamide in childhood epilepsy

    PubMed Central

    Coppola, Giangennaro

    2011-01-01

    Rufinamide is an orally active, structurally novel compound (1-[(2,6-difluorophenil1) methyl1]-1 hydro 1,2,3-triazole-4 carboxamide), which is structurally distinct from other anticonvulsant drugs. It was granted orphan drug status for the adjunctive treatment of Lennox-Gastaut syndrome (LGS) in the United States in 2004, and released for use in Europe in 2007. In January 2009, rufinamide was approved by the United States Food and Drug Administration for treatment of LGS in children 4 years of age and older. It is also approved for adjunctive treatment for partial seizures in adults and adolescents. Rufinamide’s efficacy mainly against atonic/tonic seizures in patients with LGS seems nowadays indubitable and has been confirmed both in randomized controlled trial and in open label extension studies. More recently, rufinamide was evaluated for the adjunctive treatment of childhood-onset epileptic encephalopathies and epileptic syndromes other than LGS, including epileptic spasms, multifocal epileptic encephalopathy with spasm/tonic seizures, myoclonic-astatic epilepsy, Dravet syndrome and malignant migrating partial seizures in infancy. This review updates the existing literature data on the efficacy and safety/tolerability of rufinamide in childhood-onset epilepsy syndromes. PMID:21792306

  19. Update: immunological strategies for prostate cancer.

    PubMed

    Drake, Charles G; Antonarakis, Emmanuel S

    2010-05-01

    Prostate cancer is the second most common cause of cancer-related death in US men. Along with initial therapy using surgery, radiotherapy, or cryotherapy, hormonal therapy is the mainstay of treatment. For men with advanced (metastatic) disease, docetaxel-based chemotherapy is US Food and Drug Administration (FDA)-approved, and provides a significant survival advantage. This relative paucity of treatment options drives an ongoing quest for additional treatment modalities; among these is immunotherapy. The concept that prostate cancer is a malignancy that can be targeted by the immune system may seem counterintuitive; certainly kidney cancer and melanoma are more traditionally thought of as immune responsive cancers. However, prostate cancer arises in a relatively unique organ and may express a number of proteins (antigens) against which an immune response can be generated. More importantly, several of these agents have now demonstrated a significant survival benefit in randomized controlled clinical trials, and one agent in particular (Sipuleucel-T, Dendreon Corporation, Seattle, WA) could be FDA-approved in 2010. This update summarizes recent clinical developments in the field of prostate cancer immunotherapy, with a focus on dendritic cell vaccines, virus-based vaccines, DNA-based vaccines, and cell-based vaccines. In addition, the notion of agents that target immune checkpoints is introduced. Enthusiasm for prostate cancer immunotherapy is founded upon its potential to mediate targeted, specific, tumor cell destruction without significant systemic toxicity; however, this has yet to be fully realized in the clinical arena. PMID:20425628

  20. Update on gastric varices

    PubMed Central

    Triantafyllou, Maria; Stanley, Adrian J

    2014-01-01

    Although less common than oesophageal variceal haemorrhage, gastric variceal bleeding remains a serious complication of portal hypertension, with a high associated mortality. In this review we provide an update on the aetiology, classification and management of gastric varices, including acute bleeding, prevention of rebleeding and primary prophylaxis. We describe the optimum management strategies for gastric varices including drug, endoscopic and radiological therapies, focusing on recent published evidence. PMID:24891929

  1. How Documentalists Update SIMBAD

    NASA Astrophysics Data System (ADS)

    Buga, M.; Bot, C.; Brouty, M.; Bruneau, C.; Brunet, C.; Cambresy, L.; Eisele, A.; Genova, F.; Lesteven, S.; Loup, C.; Neuville, M.; Oberto, A.; Ochsenbein, F.; Perret, E.; Siebert, A.; Son, E.; Vannier, P.; Vollmer, B.; Vonflie, P.; Wenger, M.; Woelfel, F.

    2015-04-01

    The Strasbourg astronomical Data Center (CDS) was created in 1972 and has had a major role in astronomy for more than forty years. CDS develops a service called SIMBAD that provides basic data, cross-identifications, bibliography, and measurements for astronomical objects outside the solar system. It brings to the scientific community an added value to content which is updated daily by a team of documentalists working together in close collaboration with astronomers and IT specialists. We explain how the CDS staff updates SIMBAD with object citations in the main astronomical journals, as well as with astronomical data and measurements. We also explain how the identification is made between the objects found in the literature and those already existing in SIMBAD. We show the steps followed by the documentalist team to update the database using different tools developed at CDS, like the sky visualizer Aladin, and the large catalogues and survey database VizieR. As a direct result of this teamwork, SIMBAD integrates almost 10.000 bibliographic references per year. The service receives more than 400.000 queries per day.

  2. Behavior of selected pharmaceuticals in topsoil of Greyic Phaeozem

    NASA Astrophysics Data System (ADS)

    Kodesova, Radka; Klement, Ales; Kocarek, Martin; Fer, Miroslav; Golovko, Oksana; Grabic, Roman; Jaksik, Ondrej

    2014-05-01

    It has been documented in several studies that soil may be contaminated by human or veterinary pharmaceuticals. Some of pharmaceutical ingredient may be retained in soils. The rest can be transported to the surface and groundwater through surface runoff and infiltration. Mobility of contaminants in soils is dependent on many soil and pharmaceutical properties (e.g. pharmaceutical adsorption on soil particles and pharmaceutical degradation). The goals of this study were: (1) to measure adsorption isotherms of selected pharmaceuticals in one soil; (2) to evaluate degradation of selected pharmaceuticals in this soil, and (3) to evaluate impact of applied pharmaceuticals on biological activity in soil, which influences pharmaceutical decomposition. Batch sorption tests were performed for 7 selected pharmaceuticals (beta blockers Atenolol and Metoprolol, anticonvulsant Carbamazepin, and antibiotics Clarithromycin, Clindamycin, Trimetoprim and Sulfamethoxazol) and one soil (topsoil of Greyic Phaeozem from Čáslav). The same concentrations (0.5, 1, 2.5, 5 and 10 mg/l) were used for almost all pharmaceuticals except Clarithromycin (0.033, 0.08, 0.165, 0.25, 0.33 mg/l). The Freundlich equations were used to describe adsorption isotherms. Degradation of all 7 pharmaceuticals was also studied. Solutes of different pharmaceuticals (concentration of 8.3 mg/l) were added into the plastic bottles (one pharmaceutical per bottle) with soil. Concentrations of pharmaceuticals remaining in soil 1, 2, 5, 12, 23, 40 and 61 days after the pharmaceutical application were analyzed. Colony forming unites were evaluated to describe microbial activity in time affected by different pharmaceuticals. Adsorption of studied pharmaceuticals on soil particles decreasing as follows: Clarithromycin, Trimetoprim, Metoprolol, Clindamycin, Atenolol, Carbamazepin, Sulfamethoxazol. Degradation rates in some degree reflected adsorption of studied pharmaceuticals on soil particles and increased with

  3. Jordanian pharmaceutical companies: are their marketing efforts paying off?

    PubMed

    Al-Shaikh, Mustafa S; Torres, Ivonne M; Zuniga, Miguel A; Ghunaim, Ayman

    2011-04-01

    The pharmaceuticals industry is one of the main industries in Jordan. Jordanian pharmaceuticals rank third in the export industry of this country. This study aims to examine the strengths that Jordanian pharmaceutical companies have, which, in turn, form their competitiveness base. In addition, this study aims to identify their weaknesses and the effects of marketing their products in the local market. What is the relationship between Jordanian pharmaceutical product quality, price and value, and the competitiveness of pharmaceutical companies in the local market? Our study aims to answer this and other questions. Our results and practical implications are discussed. PMID:21590563

  4. Drugs Approved for Wilms Tumor

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Wilms tumor and other childhood kidney cancers. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  5. Drugs Approved for Liver Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for liver cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  6. Drugs Approved for Esophageal Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for esophageal cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  7. Drugs Approved for Vulvar Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for vulvar cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  8. Drugs Approved for Endometrial Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for endometrial cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  9. Drugs Approved for Bone Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for bone cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  10. Drugs Approved for Penile Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for penile cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  11. FDA-Approved HIV Medicines

    MedlinePlus

    ... and acronyms) Brand Name FDA Approval Date Nucleoside Reverse Transcriptase Inhibitors (NRTIs) NRTIs block reverse transcriptase, an enzyme HIV ... AZT, ZDV) Retrovir March 19, 1987 Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) NNRTIs bind to and later alter reverse ...

  12. Drugs Approved for Pancreatic Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for pancreatic cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  13. Drugs Approved for Skin Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for skin cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  14. Drugs Approved for Vaginal Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) to prevent vaginal cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  15. Drugs Approved for Breast Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for breast cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  16. Drugs Approved for Malignant Mesothelioma

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for malignant mesothelioma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  17. Drugs Approved for Lung Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for lung cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  18. Drugs Approved for Bladder Cancer

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for bladder cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  19. Drugs Approved for Kaposi Sarcoma

    Cancer.gov

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Kaposi sarcoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  20. Gaining approval for clinical research.

    PubMed

    Cobb, Vanessa; Srinivasan, Neil; Lambiase, Pier

    2016-07-01

    Set-up and delivery of a clinical research project can be complicated and difficult. This article introduces the regulatory processes involved in gaining approval for clinical research and discusses the obstacles that may be encountered. PMID:27388381